Jump to content

Mylan: Difference between revisions

From Wikipedia, the free encyclopedia
Browse history interactively
← Previous editNext edit →
Content deleted Content added
VisualWikitext
PghPhxNfk (talk | contribs)
450 edits
PghPhxNfk (talk | contribs)
450 edits
Line 97: Line 97:


==Corporate headquarters==
==Corporate headquarters==
Founded in 1961, the company was first located in an abandoned skating rink in [[White Sulphur Springs, West Virginia|White Sulphur Springs]], [[West Virginia]].<ref name="PuskarObit">{{cite news|last1=Dearment|first1=Alaric|title=Milan Puskar, co-founder of Mylan, dies|url=http://www.drugstorenews.com/article/milan-puskar-co-founder-mylan-dies|work=Drug Store News|date=October 10, 2011}}</ref><ref>{{Cite web|url=http://www.wvexecutive.com/a-tale-of-two-entrepreneurs/|title=A Tale of Two Entrepreneurs|website=www.wvexecutive.com|language=en-US|access-date=2018-07-01}}</ref> The facility was moved to Pennsauken, New Jersey in 1962,<ref>{{Cite book|url=https://books.google.co.il/books?id=bDubfivyILEC&pg=PA7&lpg=PA7&dq=Pennsauken+mylan&source=bl&ots=uF2vM3-iyl&sig=2cZWG3YO49jsmSK2RgBYZAsinwc&hl=en&sa=X&ved=0ahUKEwj7rYPvq_zWAhXIbBoKHct2AZ8Q6AEIJjAA#v=onepage&q=Pennsauken%20mylan&f=false|title=Mylan: 50 Years of Unconventional Success : Making Quality Medicine Affordable and Accessible|last=Seaman|first=John T.|last2=Landry|first2=John T.|date=2012-04-10|publisher=UPNE|isbn=9781611682700|language=en}}</ref> to Princeton, West Virginia in 1963, and then [[Morgantown, West Virginia|Morgantown]], West Virginia, in 1965, and in 1976 it relocated its corporate headquarters to the [[Pittsburgh]] suburb of [[Cecil Township]], [[Pennsylvania]], near [[Canonsburg, PA|Canonsburg]]. Finally in 2004 it moved to a new office center in nearby [[Southpointe]], a suburban business park located in [[Cecil Township, Pennsylvania|Cecil Township]], where it is still located.<ref>{{cite web
Founded in 1961, the company was first located in an abandoned skating rink in [[White Sulphur Springs, West Virginia|White Sulphur Springs]], [[West Virginia]].<ref name="PuskarObit">{{cite news|last1=Dearment|first1=Alaric|title=Milan Puskar, co-founder of Mylan, dies|url=http://www.drugstorenews.com/article/milan-puskar-co-founder-mylan-dies|work=Drug Store News|date=October 10, 2011}}</ref><ref>{{Cite web|url=http://www.wvexecutive.com/a-tale-of-two-entrepreneurs/|title=A Tale of Two Entrepreneurs|website=www.wvexecutive.com|language=en-US|access-date=2018-07-01}}</ref> The facility was moved to Pennsauken, New Jersey in 1962,<ref>{{Cite book|url=https://books.google.co.il/books?id=bDubfivyILEC&pg=PA7&lpg=PA7&dq=Pennsauken+mylan&source=bl&ots=uF2vM3-iyl&sig=2cZWG3YO49jsmSK2RgBYZAsinwc&hl=en&sa=X&ved=0ahUKEwj7rYPvq_zWAhXIbBoKHct2AZ8Q6AEIJjAA#v=onepage&q=Pennsauken%20mylan&f=false|title=Mylan: 50 Years of Unconventional Success : Making Quality Medicine Affordable and Accessible|last=Seaman|first=John T.|last2=Landry|first2=John T.|date=2012-04-10|publisher=UPNE|isbn=9781611682700|language=en}}</ref> to Princeton, West Virginia in 1963, and then [[Morgantown, West Virginia|Morgantown]], West Virginia, in 1965, and in 1976 it relocated its corporate headquarters to the [[Pittsburgh]] suburb of [[Canonsburg]], [[Pennsylvania]]. Finally in 2004 it moved to a new office center in nearby [[Southpointe]], a suburban business park located in [[Cecil Township, Pennsylvania|Cecil Township]], where it is still located.<ref>{{cite web
|url=http://www.mylan.com/about_us/company_history.aspx
|url=http://www.mylan.com/about_us/company_history.aspx
|title=Mylan 50 years young and still making history
|title=Mylan 50 years young and still making history

Revision as of 20:01, 25 January 2019

Mylan N.V.
Mylan N.V.
FormerlyMilan
Company typePublic (under Dutch law)
Nasdaq: MYL
NASDAQ Biotechnology Component
NASDAQ-100 Component
S&P 500 Component
ISINNL0011031208
IndustryPharmaceuticals
Founded1961; 63 years ago (1961) in White Sulphur Springs, West Virginia, United States
FoundersMilan Puskar
Don Panoz
Headquarters
Cecil Township, Pennsylvania
,
United States of America
Area served
Worldwide
Key people
Heather Bresch, CEO
ProductsGeneric and specialty pharmaceuticals and active pharmaceutical ingredients
RevenueIncrease US$11.87 billion[1] (2017)
Decrease US$830.1 million (2015)
Increase US$4.216 billion (2015)
Total assetsIncrease US$ 22.267 billion (2015)
Total equityIncrease US$9.765 billion (2015)
Number of employees
~35,000[1] (2015)
Divisionssee Operations
SubsidiariesMeda
Famy Care
Websitewww.mylan.com

Mylan N.V. is a global generic and specialty pharmaceuticals company registered in the Netherlands, with principal executive offices in Hatfield, Hertfordshire, UK[2] and a "Global Center" in Cecil Township, Pennsylvania, US. In 2007, Mylan acquired a controlling interest in India-based Matrix Laboratories Limited, a top producer of active pharmaceutical ingredients (APIs) for generic drugs,[3] and the generics business of Germany-based Merck KGaA.[4] Through these acquisitions, Mylan grew from the third-largest generic and pharmaceuticals company in the United States to the second-largest generic and specialty pharmaceuticals company in the world.[5]

Mylan went public on the OTC market in February 1973.[6] It is listed on the NASDAQ,[7] and its shares are a component of NASDAQ Biotechnology,[8]NASDAQ-100,[9] and the S&P 500 indices.[10]

The company develops and produces medicines for a wide range of medical disciplines, including oncology, anaphylaxis, antiretrovirals, cardiovascular, respiratory, dermatology, immunology, anesthesia and pain management, infectious disease, gastroenterology, diabetology/endocrinology, and women's healthcare.[11]

In 2016, Mylan's pricing of the EpiPen, an epinephrine autoinjector, became controversial and was widely referred to as "price gouging". As a result, investigations were opened into whether Mylan had misclassified the EpiPen under the Medicaid Drug Rebate Program, a common form of pharmaceutical fraud. In October 2016, Mylan settled these investigations with the U.S. Department of Justice, agreeing to pay $465 million and enter into a corporate integrity agreement concerning the rebate program. In a report published on June 12, 2017 Institutional Shareholder Services criticized Mylan for the "outsized compensation" of Mylan's directors. Former CEO Robert Coury received a $98 million 2016 pay package in spite of shareholder losses and the perceived harm to the company inflicted by the EpiPen controversies. The report urged Mylan's shareholders to oust all of Mylan's existing directors.[12]

Operations

Mylan Inc. operates several divisions and subsidiaries in various regions around the world:

North & South America

  • Mylan Pharmaceuticals, based in Morgantown, West Virginia [13]
  • Mylan Pharmaceuticals ULC, based in Etobicoke, Ontario [14]
  • Mylan Technologies Inc. (MTI) - transdermal drug delivery systems (TDDS) and related technologies based in St. Albans, Vermont [15]
  • UDL Laboratories Inc. based in Rockford, Illinois
  • Somerset Pharmaceuticals Inc. a research and development company based in Tampa, Florida, owned by Mylan.[16] Somerset develops Emsam, manufactured by Mylan Technologies and marketed in the United States by Dey, later renamed Mylan Specialty [17][18][19]
  • Mylan Laboratories Limited, based in Campos dos Goytacazes, Brazil[20]

Oceania & parts of Asia

Europe, Africa, & West Asia

  • Divisions under the Mylan name in Republic of Ireland, Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, the Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, & the United Kingdom.
  • Arcana Arzneimittel GmbH based in Germany [27]
  • Generics Pharma Hellas based in Greece[28]
  • Gerard Laboratories based in Ireland [29]
  • Docpharma - generic pharmaceutical distribution company based in Belgium,[30] the Netherlands and Luxembourg [26]

Corporate headquarters

Founded in 1961, the company was first located in an abandoned skating rink in White Sulphur Springs, West Virginia.[31][32] The facility was moved to Pennsauken, New Jersey in 1962,[33] to Princeton, West Virginia in 1963, and then Morgantown, West Virginia, in 1965, and in 1976 it relocated its corporate headquarters to the Pittsburgh suburb of Canonsburg, Pennsylvania. Finally in 2004 it moved to a new office center in nearby Southpointe, a suburban business park located in Cecil Township, where it is still located.[34]

Stock

On February 23, 1973, Mylan had its initial public offering (IPO),[35] becoming a publicly traded company on the OTC market under the ticker symbol MYLN. In 1976 the stock moved to NASDAQ. Their final stock move was in 1986, when their stock became available for trade on the New York Stock Exchange under the ticker symbol MYL. Currently, the stock is traded on the NASDAQ.

History

Founding to 1980

Mylan Pharmaceuticals was founded as a drug distributor in 1961 by Milan Puskar and Don Panoz.[31] In 1966 Mylan began manufacturing penicillin G tablets as well as vitamins and other dietary supplements.[31][36]

Panoz left Mylan in 1969 and Puskar quit the company in 1973, as it grew and experienced financial difficulties. The board hired Roy McKnight as board chairman, who convinced Puskar to return in 1976.[36]

Mylan discontinued operating as a contract manufacturing organization in 1980 and instead chose to market their products under their own "Mylan-labeled" brand.[37]

1980s

With the passage of the Hatch-Waxman Act in 1984, Mylan and other small generic companies gained value; in the eighteen months following passage of the law Mylan's earnings grew 166% to $12.5 million and its stock value rose 800%.[38]

Dyazide & Maxzide

In the 1980s one of the most prescribed drugs in the US was Dyazide, a diuretic that was a combination drug containing triamterene and hydrochlorothiazide; it had been on the market since 1965 and its patents had expired in 1980.[39] Complications arose with the introductions of generics versions, because the formulation of Dyazide resulted in variable batches that made it impossible for generic manufacturers to show that their versions were bioequivalent.[40][41]

Some generic companies committed fraud trying to bring a generic version of Dyazide. Bolar Pharmaceutical had the first generic version approved in 1987,[39] but it turned out that Bolar had fraudulently substituted Dyazide for its own version to conduct studies that were submitted to the FDA. By 1989 the FDA rescinded its approval based on its suspicions and filed criminal charges against Bolar, to which Bolar eventually pled guilty in 1991.[42][43][44]

Mylan chose to develop a new version of a triamterene/hydrochlorothiazide combination drug instead of going the generic route; it developed a different, more stable formulation[41] and used different dosages of each active ingredient (50 mg hydrochlorothiazide and 75 mg triamterene, compared with Dyazide's 25 mg hydrochlorothiazide and 50 mg triamterene).[45] This drug had to get approval as a new drug, as opposed to a generic. Their product was called Maxzide and was approved in 1984.[45][46] The higher dose allowed once per day dosing, which Mylan and its marketing partner, Lederle, believed would help it compete against Dyazide, which had $210M in sales in 1983.[45] However, Mylan's patents on the drug were declared invalid in court, and its marketing exclusivity expired in 1987, prompting a rush of generic competition[47]

Mylan had concerns about the practices of its competitors and the FDA in general, and also with regard to companies seeking to bring generic versions of Maxzide. Mylan hired private investigators to examine its competitors' practices, and when it found evidence of corruption, it submitted it to the House Oversight and Investigations Committee, which investigated and found fraud and corruption within the Food and Drug Administration's generic drugs division and at other generic companies.[36] Two of the companies that had gotten approval to market generic versions of Maxzide, Vitarine Pharmaceutical and Par Pharmaceutical, were targets of Mylan's initial investigation and were found to have used Mylan's Maxzide to obtain their bioequivalence data, leading both companies to withdraw its generic competitor to Mylan's product.[36][48]

The corruption in the nascent generics industry and at the office in the FDA regulating it was widely covered in the media, and led to widespread concern among doctors and the public in the late 1980s and early 1990s that generic drugs were not really the same as the branded drugs they were meant to replace.[42][49][40]

Acquisitions begin

In 1987 Mylan agreed to enter into a joint venture with Bolar to buy Somerset Pharmaceuticals; Mylan wanted access to Somersets' drug discovery capabilities as well as its new drug for Parkinson's, selegiline; the deal was completed in 1988 but its consummation was dependent on FDA approval of selegiline, which came in 1989.[36][50][51]

1990s

Mylan acquired Bertek Inc. in 1993 for its transdermal patch technologies, and kept it as a subsidiary. In 1999 Mylan renamed the company Mylan Technologies Inc. (MTI).[52] MTI eventually came to be the contract manufacturer for the selegiline transdermal patch and was the first company to market generic nitroglycerin, estradiol, clonidine, and fentanyl transdermal patches.[52]

In 1996 Mylan acquired UDL Laboratories, a supplier of unit dose generic medications to institutional and long-term care facilities.[53]

In 1998 when it was the world's second largest generics company, Mylan came under investigation from the Federal Trade Commission after it raised the prices of its products, tripling them in the case of lorazepam. Mylan had entered into an exclusive agreement with Profarmica, an Italian company that supplied drug ingredients, after which Mylan's competitors had higher prices and a diminished supply of raw ingredients for lorazepam and other drugs.[54] Before the round of price increases the price of generic drugs had been 5 - 10% of the price of branded drugs and afterwards it was around 50%.[54] The FTC filed suit at the end of 1998 and 32 states filed parallel actions. The case was settled in 2000, with Mylan paying a total of $147M -- $100M in disgorged profits into a fund to reimburse consumers and state agencies that had overpaid, $8 million in attorney's fees to the State Attorneys General, $35 million, plus $4 million in attorney's fees, to settle certain class actions with insurers and managed care organizations—and Mylan and three ingredient suppliers (Cambrex Corporation, Profarmaco S.R.L., and Gyma Laboratories) also agreed to an injunction barring them from entering into similar anticompetitive agreements in the future.[55][56]

2000s

Attempted King Pharmaceuticals acquisition

In 2004 Mylan and King Pharmaceuticals began discussing a deal in which Mylan would acquire King for about $4B; Mylan wanted to expand its presence in branded pharmaceuticals and to acquire King's sales force.[57] The deal was complicated by a number of factors, and included an SEC investigation into King's accounting and Carl Icahn obtaining a 9.8% interest in Mylan and becoming its largest stakeholder in order to kill the deal. The parties called off the deal in February 2005.[57] Afterwards, Icahn offered to buy Mylan for $5.4B[58] and nominated a slate of board members to change the direction of Mylan; he won three seats in May 2005.[59] In June Mylan bought back 25% of its shares in order to fend off Icahn.[60] In July Icahn gave up his bid and sold his shares.[61]

Matrix acquisition

In August 2006 Mylan announced that it had reached an agreement to buy a controlling interest in Matrix Laboratories, an Indian supplier of active pharmaceutical ingredients. The deal gave Mylan access to markets in India and China and was completed in January the next year.[62][63]

EpiPen acquisition

In May 2007 Mylan and Merck KGaA agreed that Mylan would acquire Merck's generics arm for $6.6B. The deal was completed that October and tripled the size of Mylan.[64][65] Mylan acquired the rights to market the EpiPen in the transaction. At that time annual sales were around $200 million[66] and the EpiPen had about 90% of the market.[67]

In 2009, the company filed two lawsuits against the Pittsburgh Post-Gazette after the newspaper ran an article that was critical of the quality control procedures used at the company's Morgantown plant.[68][69] The company had earlier quality control issues involving the FDA.[70] The lawsuits were dropped in 2012 without any damages paid by the Post-Gazette, which stated "The Post-Gazette did not find and did not intend to report that Mylan had manufactured or distributed any defective drugs. The Post-Gazette regrets if any reader of the article thought otherwise."[71]

Also in 2009, Mylan and its subsidiary UDL agreed to pay a $118M to settle a suit filed under the False Claims Act in which Mylan/UDL and two other companies were accused of underpaying states under the Medicaid Drug Rebate Program. The program requires drug companies to give rebates to states under Medicaid and the rebates are higher for new drugs than for generics; the suit said that the companies sold new drugs but paid rebates as if they were generics.[72]

2010s

Generic Advair agreement

In 2011, Mylan entered into an agreement with Pfizer for the exclusive worldwide rights to develop, manufacture and commercialize Pfizer's generic equivalent to GlaxoSmithKline's Advair (US)/Seretide (UK) Diskus incorporating Pfizer's proprietary dry powder inhaler delivery platform.[73] Mylan launched the product in the UK in 2015[74] and in February 2016 the FDA accepted its ANDA, putting it in line behind Hikma and Sandoz to launch a generic version in the US.[75]

EpiPen4Schools Launch

In 2012, Mylan launched a program called EpiPen4Schools to sell EpiPens in bulk and with discounts to schools. To participate in the program schools had to agree not to buy epinephrine autoinjectors from any other company for a year, a requirement which a Mylan spokesperson said is no longer part of its program.[76]

In December 2012, the National Association of State Boards of Education launched a policy initiative designed to "help state boards of education as they develop student health policies regarding anaphylaxis and epinephrine auto-injector access and use," and advocated for state laws protecting school from legal liability for stocking and using epinephrine autoinjectors. Gayle Manchin, the mother of Mylan's CEO, Heather Bresch, had become president of the association in 2010, and shortly after had discussed donations from her "daughter's company" to the association. Manchin had been appointed to the West Virginia state school board by her husband, then-governor of the state Joe Manchin, in 2007. In a statement, Mylan said, "There is no truth to the suggestion that the company's efforts were anything but straightforward or that we are aware of anyone advocating inappropriately for the right of schoolchildren to have access to potential life-saving medicine." [77]

After successful lobbying from Mylan,[66] in 2013, the "School Access to Emergency Epinephrine Act" became law after passing Congress with broad and bipartisan support; it protected anyone from liability if they administered epinephrine to a child in a school (previously, only trained professionals or the affected person were allowed to administer the drug, and were open to liability), and it provided some financial incentives for schools that didn’t already stock epinephrine autoinjector to start stocking them.[78] Joe Manchin, the father of Mylan's CEO, was a senator at that time.[77]

Agila acquisition

In 2013 Mylan acquired an Indian generic injectable drugs company, Agila Specialties Private, for $1.6 billion in cash.[79] In 2015 three plants acquired in that deal were issued warning letters by the FDA.[80]

Abbott acquisition

In July 2014, Mylan and Abbott Laboratories announced an agreement under which Mylan would buy Abbott's generic drugs business in developed markets for stock valued at about $5.3 billion.[81] Mylan acquired Mumbai-based Famy Care and expand its presence in the market for women's contraceptives at about $750 million.[82]

Attempted Perrigo acquisition

In April 2015, Mylan tried negotiating with the management of Irish pharmaceutical firm Perrigo to acquire the company, and when those negotiations failed Mylan attempted a hostile takeover, offering to buy $26B in shares directly from shareholders. Too few shareholders agreed to sell their stock by the deadline set in November 2015 and the effort failed.[83]

Attempted purchase by Teva

Two weeks after Mylan made its first offer for Perrigo, Teva Pharmaceutical offered to buy Mylan for $40B; the combined companies would have been the world's largest generic company and the 9th biggest drug company in the world.[84] In July, Teva dropped its bid for Mylan and instead acquired Allergan's generic drug business for about the same price.[85][86]

New COPD drug

In June 2015, Mylan agreed to work with Pulmatrix, a company with a proprietary inhaled drug delivery platform, to co-develop a product to treat for chronic obstructive pulmonary disease; the product was PUR0200, a generic drug in a Pulmatrix device.[87]

Meda acquisition

In February 2016, the company announced it would acquire Meda for $9.9 billion.[88] In May of the same year the company announced it would acquire Renaissance Acquisition Holdings dermatology division for up to $1 billion.[89]

In December 2016, the attorneys general of 20 states filed a civil complaint accusing Mylan of a coordinated scheme to artificially maintain high prices for a generic antibiotic and diabetes drug. The complaint alleged price collusion schemes between six pharmaceutical firms including informal gatherings, telephone calls, and text messages.[90]

In October 2017, the company announced the launch of the first FDA-approved generic of Teva’s long-acting Copaxone. Approximately 3 months later, Credit Suisse analyst Vamil Divan cited IMS Health data which showed that the new generic accounted for 10% of the market.[91]

In May 2018, Mylan announced a collaboration with West Virginia University to expose children across West Virginia to STEM educational initiatives.[92]

Acquisition history

The following is an illustration of the company's major mergers and acquisitions and historical predecessors:

Mylan
 

Renaissance Acquisition Holdings
(Dermatology div, Acq 2016)

 

Meda
(Acq 2016)

 

Famy Care
(Acq 2014)

 

Abbott Laboratories
(Generics div, Acq 2014)

 

Agila Specialties
(Acq 2013)[93]

 

Pfizer Respiratory Delivery Platform
(Acq 2011)[94]

 

Bioniche Pharma Holdings
(Acq 2010)[95]

 

Merck KGaA
(Generics div, Acq 2007, renamed Mylan Laboratories Inc)

 

Matrix Laboratories
(Acq 2007, renamed Mylan Laboratories)[96]

 

Penederm Inc.
(Acq 1998)[97]

 

UDL Laboratories
(Acq 1996)

 

Bertek Inc
(Acq 1993, renamed Mylan Technologies Inc)

 

Dow B. Hickam
(Acq 1991)[98]

 

Somerset Pharmaceuticals
(Acq 1989)[99]

Milan Pharmaceuticals
(Founded 1961)

Criticism

EpiPen pricing

See also: Epinephrine autoinjector § Price
See also: Heather Bresch § Mylan executive

Mylan acquired the right to market and distribute the EpiPen line of epinephrine autoinjector devices from Merck KGaA as part of their 2007 deal;[100] that right had formerly been held by Dey LP, a wholly owned subsidiary of Merck.[101] According to Bloomberg the devices deliver about $1 worth of drug.[66] At that time annual sales were around $200M.[66] Bresch, the company's CEO, saw an opportunity to increase sales through marketing and advocacy, and the company launched a marketing campaign to increase awareness of the dangers of anaphylaxis for people with severe allergies that made the brand "EpiPen" as identified with its product as "Kleenex" is with facial tissue. The company also successfully lobbied the FDA to broaden the label to include risk of anaphylaxis and in parallel, successfully lobbied Congress to generate legislation making EpiPens available in schools and in public places like defibrillators are, and hired the same people that Medtronic had worked with on defibrillator legislation to do so.[66] Mylan's efforts to gain market dominance were aided when Sanofi's competing product was recalled in November 2015 and further when Teva's generic competitor was rejected by the FDA in March 2016.[102]

By the first half of 2015, Mylan had an 85% market share of such devices in the US[66] and in that year sales reached around $1.5B and accounted for 40% of Mylan's profit.[103] Those profits were also due in part to Mylan's continually raising the price of EpiPens starting in 2009; in 2009 the wholesale price of two EpiPens was about $100, by July 2013 the price was about $265, in May 2015 it was around $461, and in May 2016 the price rose again to around $609,[100] around a 500% jump from the price in 2009.[104]

Starting in 2014, according to a 2017 report in the New York Times, mid-level executives began questioning the rate at which the company had increased and was planning to continue to increase the price of the Epi-Pen, and raising concerns that the price increases were unethical; the Times reported that when these concerns were brought to Robert Coury, the chairman of the board, Coury "replied that he was untroubled. He raised both his middle fingers and explained, using colorful language, that anyone criticizing Mylan, including its employees, ought to go copulate with themselves. Critics in Congress and on Wall Street, he said, should do the same. And regulators at the Food and Drug Administration? They, too, deserved a round of anatomically challenging self-fulfillment."  The Times reported that Bresch provided similarly dismissive responses.[105] The Times reporter noted that "Those top leaders’ responses are a far cry from the message on Mylan’s website, which says that 'we challenge every member of every team to challenge the status quo,' and that 'we put people and patients first, trusting that profits will follow.'", and also noted that "The firm is a case study in the limits of what consumer and employee activism, as well as government oversight, can achieve." [105][106][107][108]

In the summer of 2016, as parents prepared to send their children back to school and went to pharmacies to get new EpiPens, people began to express outrage at the cost of the EpiPen and Mylan was widely and harshly criticized,[109][110] including criticism from Martin Shkreli, "poster boy for grasping pharma greed," letters from two Senators and initiation of Congressional investigations.[103][111] Mylan's pricing of the EpiPen was widely referred to as price gouging.[112][113][114] The last price increase coincided with Mylan's airing of a new line of TV commercials that were described as "shocking" and "no holds barred", depicting an anaphylactic reaction from the point of view of the young woman having it at a party, and ending with the young woman seeing her swollen and hive-covered face in the mirror before she collapses.[115] In response to criticism, Mylan increased financial assistance available for some patients to purchase EpiPens,[116] a gesture that was called a "classic public relations move" by Harvard Medical School professor Aaron Kesselheim.[117] The up to $300 saving cards can only be used by a small number of people who need the drug, and no one on Medicaid. They do nothing about the high price which is still being paid by insurers, who ultimately pass the cost onto consumers.[117] Mylan further responded by releasing the first authorized generic version of the EpiPen in December 2016 at a more than 50% discount.[118]

In September 2016, the New York State Attorney General began an investigation into Mylan's EpiPen4Schools program in New York to determine if the program's contracts violated antitrust law[119] and the West Virginia State Attorney General opened an investigation into whether Mylan had given the state the correct discount under the Medicaid Drug Rebate Program and subpoenaed the company when it refused to provide the documentation the state requested.[120]

In October 2016 the CEO of Mylan testified to Congress that Pfizer/King charged Mylan about $34.50 for one device.[121] In September 2016, a Silicon Valley engineering consultancy performed a teardown analysis of the EpiPen and estimated the manufacturing and packaging costs at about $10 for a two-pack.[122]

According to the Department of Health and Human Services' Office of Inspector General analysis, the U.S. government may have overpaid "as much as $1.27 billion between 2006 and 2016" to drugmaker Mylan N.V. for the EpiPen emergency allergy treatment. This represents three times the proposed settlement of $465 million announced by Mylan in October 2016. In October 2016, Mylan announced a settlement with the US Department of Justice over rebates paid by Mylan to states under the Medicaid Drug Rebate Program.[123] Questions had been raised by Congress and others about why EpiPen had been classified as a generic rather a proprietary product in the program since 1997; generic drugs have lower rebates (13%) than proprietary drugs (23%), and price hikes for generic drugs cannot be passed onto states, and a common form of pharmaceutical fraud involves misclassifying proprietary drugs as generic under the program.[124] Under the agreement Mylan agreed to pay a $465 million payment and to a sign a corporate integrity agreement requiring it to perform better in the future;[123] the settlement also resolved cases brought by states related to the rebates.[125] Simultaneously with the settlement Mylan also announced it was being investigated by the Securities and Exchange Commission related to the drug rebate program.[126] Republican Senator Chuck Grassley, chair of the Senate Judiciary Committee that launched the "probe of EpiPen pricing probe in 2016, released the analysis on May 30, 2017.[127] On the same day, a group of Mylan "investment funds urged shareholders to vote against the re-election of the company's directors after it paid Chairman Robert Coury over $97 million last year."[127]

Execution drugs

Mylan manufactures rocuronium bromide, which is approved by the state of Alabama for use in executions by lethal injection. European manufacturers refuse to sell drugs which can be used for executions to the United States, except to distributors or users who sign legally binding agreements that the drug will not be used for executions down the delivery chain.[128]

In September 2014, the London-based human rights organization Reprieve told Mylan that they were the only FDA-approved manufacturer of rocuronium bromide without legal controls in place to prevent its use in executions, and there was "a very real risk that Mylan may soon become the go-to provider of execution drugs for states across the country". The German asset manager DJE Kapital [de] divested itself of $70 million in Mylan shares for that reason. Mylan said that their distribution was "legally compliant," [128] and that their restrictions did "prohibit resale to correctional facilities for use in lethal injections." [129]

Recalls

In 2018, valsartan manufactured by Mylan was recalled due to the detection of N-nitrosodiethylamine (NDEA) which is a probable human carcinogen.[130]

Products

Generic Medicines

Name Indication Year Introduced
Penicillin G tablets Antibiotic 1966[131]
Tetracycline Antibiotic 1968[132]
Cimetidine Ulcer 1994[133]
Cipro (Ciprofloxacin) Antibiotic 2004[134]

Branded Medicines

Name Indication Year Introduced
Maxzide Blood pressure 1984[135]
Eldepryl Parkinson's 1989[136]
EpiPen Allergy 2007[137]

Management

Heather Bresch is Executive Director and has served as the CEO of Mylan since 2012.[138] Robert Coury serves as Chairman,[139] and Rajiv Malik is President.[140]

References

  1. ^ a b "Public Filings -- Form 10-K". Mylan Investor's Relations. Retrieved August 26, 2016.
  2. ^ Mylan NV 10-K for the Fiscal Year Ended December 31, 2015
  3. ^ "Mylan buys part of drug maker". Pittsburgh Business Times. December 30, 2013.
  4. ^ "Mylan Laboratories To Acquire Generics Business Of Merck KGaA For 4.9 Billion Euros". Medical News Today. May 26, 2007.
  5. ^ "Pharmaceutical giants tracking Mylan's prosperity". The Pittsburgh Tribune-Review. August 13, 2008. Archived from the original on September 8, 2008. {{cite news}}: Unknown parameter |deadurl= ignored (|url-status= suggested) (help)
  6. ^ "History of Mylan Laboratories Inc. – FundingUniverse". www.fundinguniverse.com. Retrieved June 11, 2018.
  7. ^ "Mylan N.V." MarketWatch. Retrieved June 11, 2018.
  8. ^ "iShares Nasdaq Biotechnology Index Fund (IBB)". NASDAQ.com. Retrieved June 11, 2018.
  9. ^ MarketNewsVideo.com (September 27, 2017). "Mylan Becomes #48 Most Shorted Nasdaq 100 Component, Replacing Walgreens Boots Alliance". TheStreet. Retrieved June 11, 2018.
  10. ^ "Market Realist". marketrealist.com. Retrieved June 11, 2018.
  11. ^ "Therapeutic Innovation". www.mylan.com. Retrieved August 8, 2018.
  12. ^ Egan, Matt. "EpiPen maker faces revolt over exec's $98 million pay package". CNN Money.
  13. ^ "Mylan's Morgantown Facility is Mammoth State of the Art". Retrieved June 11, 2018. {{cite web}}: Cite has empty unknown parameter: |dead-url= (help)
  14. ^ "Mylan Pharmaceuticals ULC: Private Company Information - Bloomberg". www.bloomberg.com. Retrieved June 11, 2018.
  15. ^ "Mylan Technologies Inc. Expands, Adds 160 New Jobs | BioSpace". BioSpace. Retrieved June 11, 2018.
  16. ^ "Somerset Pharmaceuticals, Inc.: Private Company Information - Bloomberg". www.bloomberg.com. Retrieved June 11, 2018.
  17. ^ "Brand Name Medicines - Mylan". dey.com.
  18. ^ "About Us". mylan.com.
  19. ^ "Dey Pharma to Change to Mylan". www.bizjournals.com. Retrieved June 11, 2018. {{cite web}}: Cite has empty unknown parameter: |dead-url= (help)
  20. ^ "Contatar | Mylan". www.mylan.com.br. Retrieved June 11, 2018.
  21. ^ "Better health for a better world" (PDF). March 2016. Retrieved June 11, 2018. {{cite web}}: Cite has empty unknown parameter: |dead-url= (help)
  22. ^ "Japan Pharmaceutical Manufacturers Association (JPMA)". www.jpma.or.jp. Retrieved June 11, 2018.
  23. ^ "Contact | Mylan". www.mylan.com.au. Retrieved June 11, 2018.
  24. ^ "Agila Specialties Private Limited: Private Company Information - Bloomberg". www.bloomberg.com. Retrieved June 11, 2018.
  25. ^ "Mylan recalls Bangalore unit cancer drug". dna. June 16, 2015. Retrieved June 11, 2018.
  26. ^ a b "About Us". mylan.com.
  27. ^ "Generics Pharma Hellas E.P.E.: Private Company Information - Bloomberg". www.bloomberg.com. Retrieved June 11, 2018.
  28. ^ http://www.manta.com/coms2/dnbcompany_wsklv1
  29. ^ "Mylan to create 500 jobs in €380m expansion". RTE.ie. April 18, 2012. Retrieved June 11, 2018.
  30. ^ "Committee on Energy and Commerce" (PDF). Retrieved June 11, 2018. {{cite web}}: Cite has empty unknown parameter: |dead-url= (help)
  31. ^ a b c Dearment, Alaric (October 10, 2011). "Milan Puskar, co-founder of Mylan, dies". Drug Store News.
  32. ^ "A Tale of Two Entrepreneurs". www.wvexecutive.com. Retrieved July 1, 2018.
  33. ^ Seaman, John T.; Landry, John T. (April 10, 2012). Mylan: 50 Years of Unconventional Success : Making Quality Medicine Affordable and Accessible. UPNE. ISBN 9781611682700.
  34. ^ "Mylan 50 years young and still making history". Mylan. Retrieved April 18, 2012.
  35. ^ "MYL Stock History - Mylan". Retrieved August 25, 2016.
  36. ^ a b c d e Freudenheim, Milt (September 10, 1989). "Exposing the F.D.A." New York Times.
  37. ^ Letter, The Pharma. "Mylan Laboratories". www.thepharmaletter.com. Retrieved April 27, 2018.
  38. ^ Lewis, Ralph A. (1992). "The Emerging Effects of the Drug Price Competition and Patent Term Restoration Act of 1984". Journal of Contemporary Health Law & Policy. 8 (1): 361–378.
  39. ^ a b Ron Wolf for the Philadelphia Inquirer. August 22, 1987 Smithkline Loses Exclusive Rights To Drug
  40. ^ a b Boehm, Garth; Yao, Lixin; Han, Liang; Zheng, Qiang (September 2013). "Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984". Acta Pharmaceutica Sinica B. 3 (5): 297–311. doi:10.1016/j.apsb.2013.07.004.
  41. ^ a b John Seaman and John T. Landry. Mylan 50 Years of Unconventional Success. Mylan, in association with University Press of New England, 2011. ISBN 9781611682700. Page 50
  42. ^ a b Strickland, Carol (October 15, 1989). "Bolar: A Drug Company Under Siege". The New York Times.
  43. ^ Shaw, Donna (February 27, 1991). "U.s. Charges Bolar Pharmaceutical With Misrepresenting Its Products". Philadelphia Inquirer.
  44. ^ Freudenheim, Milt (February 28, 1991). "Bolar Plans Guilty Plea On Generics". The New York Times.
  45. ^ a b c Pink Sheet October 22, 1984 Mylan's Maxzide is "Approvable" at FDA: Lederle To Market Brand Competition to Smithkline's No. 3-Ranked Dyazide; Final Approval Anticipated "Imminently"
  46. ^ FDA Approval History NDA 019129: Maxzide Page accessed September 8, 2016
  47. ^ Reid, Kenneth (November 17, 1987). "US Judge to Rule on Drug Marketing". Journal of Commerce.
  48. ^ Andrews, Edmund L. (July 31, 1989). "F.D.A. Inquiry on Generic Drugs Focuses on Changes in Ingredients". The New York Times.
  49. ^ Cimons, Marlene (August 29, 1989). "FDA to Lift OK of Last Dyazide Generic Version". Los Angeles Times.
  50. ^ "Bolar and Mylan Team to Purchase Somerset Labs". Pink Sheet. November 14, 1988.
  51. ^ "Somerset Eldepryl June 5 Approval Clears Way For Mylan/Bolar Acquisition". Pink Sheet. June 12, 1989.
  52. ^ a b Ku, Mannching Sherry (December 1, 2015). "Recent trends in specialty pharma business model". Journal of Food and Drug Analysis. 23 (4): 595–608. doi:10.1016/j.jfda.2015.04.008.
  53. ^ Mylan Form 10-K (annual report)) for the Financial year ending March 31, 1996, filed June 26, 1996
  54. ^ a b Labaton, Stephen (December 5, 1998). "A Drug Maker Is Said to Face A Suit on Prices". The New York Times.
  55. ^ "Press release: FTC Reaches Record Financial Settlement To Settle Charges of Price-fixing in Generic Drug Market | Federal Trade Commission". FTC. November 29, 2000.
  56. ^ Labaton, Stephen (July 13, 2000). "Generic-Drug Maker Agrees to Settlement In Price-Fixing Case". The New York Times.
  57. ^ a b Creswell, Julie (March 21, 2005). "Icahn the Spoiler". Fortune.
  58. ^ Pollack, Andrew (November 20, 2004). "Icahn Offers $5.4 Billion for Mylan, Drug Maker". The New York Times.
  59. ^ O'keefe, Eric (May 12, 2005). "Icahn Slate Wins Seats on Blockbuster Board". The New York Times.
  60. ^ Lazo, Shirley A. "Survival Strategy". Barrons.
  61. ^ "Icahn Drops Bid for Mylan". Los Angeles Times. Bloomberg News. July 29, 2005.
  62. ^ "Mylan Signs US$736-mil. Takeover Deal for India's Matrix Laboratories". IHS. August 28, 2006.
  63. ^ "Mylan's Acquisition of Matrix: Business Strategy Case Study". ICRM.
  64. ^ Massey, Steve (May 13, 2007). "Mylan buys Merck generic drug unit for $6.6 billion". Pittsburgh Post-Gazette.
  65. ^ "Press release: Mylan Completes Acquisition of Generics Business of Merck KGaA". Mylan. October 2, 2007.
  66. ^ a b c d e f Cynthia Koons and Robert Langreth for Bloomberg Businessweek. September 23, 2015 How Marketing Turned the EpiPen Into a Billion-Dollar Business
  67. ^ Johnson, Carolyn Y.; Ho, Catherine (August 25, 2016). "How Mylan, the EpiPen company, maneuvered to create a virtual monopoly". The Washington Post via The Chicago Tribune.
  68. ^ Adams, Russell (October 30, 2009). "Mylan Again Sues Pittsburgh Post-Gazette". Wall Street Journal. Retrieved August 26, 2016.
  69. ^ Sabatini, Patricia; Boselovic, Len (July 26, 2009). "Mylan workers overrode drug quality controls Internal report detailed 'pervasive' practice of ignoring safety procedures". Pittsburgh Post-Gazette. Retrieved August 26, 2016.
  70. ^ Edwards, Jim (July 28, 2009). "It's Not Mylan's First Quality Control Beef With FDA". Money Watch. CBS News. Retrieved August 26, 2016.
  71. ^ "Mylan, Pittsburgh Post-Gazette settle lawsuits". CBS News. Associated Press. February 17, 2012. Retrieved August 26, 2016.
  72. ^ US Department of Justice. October 19, 2009 Press Release: Four Pharmaceutical Companies Pay $124 Million for Submission of False Claims to Medicaid
  73. ^ "Mylan acquires rights to Pfizer's inhaler technology". drugstorenews.com. Retrieved May 1, 2012.
  74. ^ Stanton, Dan (June 8, 2015). "GSK breathes freely as Mylan launches Seretide generic in UK". in-Pharma Technologist.
  75. ^ Helfand, Carly (February 22, 2016). "Mylan joins the Advair-copycat queue, but approval could be a long slog". FiercePharma.
  76. ^ Swetlitz, Ike; Silverman, Ed (August 26, 2016). "Mylan may have violated antitrust law in its EpiPen sales to schools". PBS Newshour.
  77. ^ a b O'Donnell, Jayne (September 21, 2016). "Family matters: EpiPens had high-level help getting into schools". USA Today.
  78. ^ Novak, Matt (August 23, 2016). "How Congress, the FDA, and Sarah Jessica Parker Helped EpiPen Become a $1 Billion Business". Gizmodo.
  79. ^ Thomas, Katie (February 27, 2013). "Mylan Buys Drug Maker of Generic Injectables". New York Times.
  80. ^ Palmer, Eric (August 18, 2015). "UPDATED: FDA castigates three Mylan sterile drug plants in warning letter". FiercePharma.
  81. ^ ABC News. "Business News, Personal Finance and Money News - ABC News". ABC News. Retrieved July 14, 2014.
  82. ^ "US drugmaker Mylan to acquire Famy Care for $750 Million". timesofindia-economictimes. February 3, 2015.
  83. ^ Koons, Cynthia (November 13, 2015). "Mylan's Hostile Bid for Perrigo Fails". Bloomberg.
  84. ^ Rockoff, Jonathan D.; Mattioli, Dana (April 22, 2015). "Teva Offers to Buy Mylan for $40 Billion". Wall Street Journal.
  85. ^ "Teva to Buy Allergan's Generic Drug Unit". Bloomberg.com. July 27, 2015.
  86. ^ Chitra Somayaji (July 27, 2015). "Teva Snaps Up Allergan's Generics Arm, Dumping Mylan". Bloomberg.com.
  87. ^ "Mylan to Co-Develop Pulmatrix' COPD Candidate". GEN.
  88. ^ "Mylan to Acquire Meda for $9.9B - GEN News Highlights - GEN". Retrieved August 25, 2016.
  89. ^ "Mylan snaps up dermatology biz from investors in $1B deal - FiercePharma". Retrieved August 25, 2016.
  90. ^ Thomas, Katie (December 15, 2016). "20 States Accuse Generic Drug Companies of Price Fixing". The New York Times. Retrieved December 16, 2016.
  91. ^ Helfand, Carly (January 4, 2018). "Look out, Teva: Mylan's Copaxone copy has already captured serious share". FiercePharma. Retrieved July 9, 2018.
  92. ^ Hudock, Megan (May 14, 2018). "Mylan and WVU announce 10 year collaboration". WBOY. Retrieved June 11, 2018.
  93. ^ Editorial, Reuters. "Mylan to buy Agila Specialties from India's Strides for $1.6 bln". U.S. Retrieved June 11, 2018. {{cite news}}: |first= has generic name (help)
  94. ^ "Mylan to acquire Pfizer respiratory tech for $17.5M | FiercePharma". www.fiercepharma.com. Retrieved June 11, 2018.
  95. ^ Grogan, Kevin (July 15, 2010). "Mylan acquires Ireland's Bioniche Pharma". www.pharmatimes.com. Retrieved June 11, 2018.
  96. ^ "US pharma major Mylan buys Matrix Labs". The Economic Times. August 29, 2006. Retrieved June 11, 2018.
  97. ^ "Mylan Fleshing Out Deal for Penederm / Skin-drug firm to sell for $205 million". SFGate. Retrieved June 11, 2018.
  98. ^ "Mylan Labs, Dow B. Hickam set plans for stock-swap merger". UPI. Retrieved June 11, 2018.
  99. ^ "Mylan buys out Watson's interest in Somerset Pharmaceuticals". www.bizjournals.com. Retrieved June 11, 2018.
  100. ^ a b Tara Parker-Pope and Rachel Rabkin Peachman for the New York Times. August 22, 2016 EpiPen Price Rise Sparks Concern for Allergy Sufferers
  101. ^ King Pharmaceuticals October 21, 2002. Press Release: King Pharmaceuticals to Acquire Meridian Medical Technologies
  102. ^ Carly Helfand for FiercePharma March 1, 2016 FDA swats down Teva's EpiPen copy, putting Mylan in cruise control
  103. ^ a b Emily Willingham for Forbes. August 21, 2016 Why Did Mylan Hike EpiPen Prices 400%? Because They Could
  104. ^ Bartolotta, Devin (August 18, 2016). "Cost Jumps Nearly 500-Percent For Life-Saving EpiPens". CBS Baltimore. Retrieved August 19, 2016.
  105. ^ a b Duhigg, Charles (June 4, 2017). "Outcry Over EpiPen Prices Hasn't Made Them Lower". The New York Times.
  106. ^ Novak, Matt (June 5, 2017). "Drug Company Chairman to America: Go Fuck Yourself". Gizmodo.
  107. ^ Mole, Beth (June 5, 2017). "Mylan chairman: Drug pricing critics ought to go copulate with themselves". Ars Technica.
  108. ^ Loew, Derek (June 12, 2017). "Mylan Begins Harvesting the Crop It's Sown". In the Pipeline.
  109. ^ Goldberg, Kenny. "People With Food Allergies Say Life-Saving Drug Too Expensive". KPBS Public Media. Retrieved June 8, 2016.
  110. ^ Walker, Joseph; Winslow, Ron; Steele, Anne (August 30, 2016). "Mylan to Launch Cheaper Generic EpiPen Alternative". Wall Street Journal.
  111. ^ Emma Court for MarketWatch. August 18, 2016 Mylan’s EpiPen price increases are Valeant-like in size, Shkreli-like in approach
  112. ^ Brad Tuttle for Time August 22, 2016 5 Signs That EpiPen Prices Are Completely Out of Control
  113. ^ Michael Hiltzik for the Los Angeles Times. August 23, 2016 Another reason to hate Mylan, which jacked up the price of life-saving EpiPens: It's a tax dodger
  114. ^ Matt Novak for Gizmodo. August 23, 2016 How Congress, the FDA, and Sarah Jessica Parker Helped EpiPen Become a $1 Billion Business
  115. ^ Beth Snyder Bulik for FiercePharma. May 1, 2016 No holds barred in Mylan’s ultra-realistic peanut allergy campaign
  116. ^ "Mylan to provide EpiPen cost assistance as CEO is asked to testify on price hike". The Guardian.
  117. ^ a b Carolyn Y. Johnson (August 25, 2016). "Why Mylan's 'savings card' won't make EpiPen cheaper for all patients". Washington Post. Washington Post.
  118. ^ Ramsey, Lydia (December 16, 2016). "The $300 generic EpiPen is here". Business Insider. Retrieved August 16, 2018.
  119. ^ Larson, Erik; Hopkins, Jared S. (September 6, 2016). "Mylan's EpiPen School Sales Trigger N.Y. Antitrust Probe". Bloomberg. Retrieved September 7, 2016.
  120. ^ Feeley, Jef; Langreth, Robert (September 20, 2016). "Mylan Investigations Mount as West Virginia Opens Fraud Probe". Bloomberg News.
  121. ^ Popken, Ben (September 30, 2016). "Upgraded EpiPens torn apart. Tech firm: "It's the same core device"". NBC News.
  122. ^ Tracy, Seipel. "Silicon Valley engineers figure real cost to make lifesaving auto-injector two-pack". The Mercury News. Retrieved October 1, 2016.
  123. ^ a b Thomas, Katie (October 7, 2016). "Mylan to Settle EpiPen Overpricing Case for $465 Million". The New York Times.
  124. ^ Thomas, Katie (September 2, 2016). "Is EpiPen a Brand-Name or a Generic Drug? Mylan Casts It Both Ways". The New York Times.
  125. ^ Mole, Beth (October 7, 2016). "For ripping off Medicaid, EpiPen maker Mylan pays Feds $465 million". Ars Technica. Retrieved October 8, 2016.
  126. ^ ZTracer, Zachary Tracer (October 7, 2016). "Mylan Agrees to $465 Million EpiPen Settlement With U.S." Bloomberg.com.
  127. ^ a b Erman, Michael (May 31, 2017). "Mylan may have overcharged U.S. for EpiPen by $1.27 billion: HHS". Reuters. New York. Retrieved May 31, 2017.
  128. ^ a b Owen Dyer (October 24, 2014). "Drug company is targeted for refusing to adopt ban on distribution of execution drug". BMJ. 2014 (349): g6452. doi:10.1136/bmj.g6452. {{cite journal}}: Cite has empty unknown parameter: |authors= (help)
  129. ^ "Mylan Statement on its Policy Against the Use of Mylan Products in Capital Punishment". Mylan. Retrieved June 25, 2018.
  130. ^ "Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient". 2018. Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths).
    Out of an abundance of caution, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC).
  131. ^ "Milan Puskar, co-founder of Mylan, dies - Drug Store News". Drug Store News. October 10, 2011. Retrieved July 17, 2018.
  132. ^ "Drugs@FDA: FDA Approved Drug Products". www.accessdata.fda.gov. Retrieved July 17, 2018.
  133. ^ "Drugs@FDA: FDA Approved Drug Products". www.accessdata.fda.gov. Retrieved July 17, 2018.
  134. ^ "FDA approves generic forms of ciprofloxacin". CIDRAP. Retrieved July 17, 2018.
  135. ^ "MYLAN's MAXZIDE IS "APPROVABLE" AT FDA: LEDERLE TO MARKET BRAND COMPETITION TO SMITHKLINE's No. 3-RANKED DYAZIDE; FINAL APPROVAL ANTICIPATED "IMMINENTLY"". Pink Sheet. October 22, 1984. Retrieved July 17, 2018.
  136. ^ "SOMERSET ELDEPRYL JUNE 5 APPROVAL CLEARS WAY FOR MYLAN/BOLAR ACQUISITION". Pink Sheet. June 12, 1989. Retrieved July 17, 2018.
  137. ^ Kusjanto, Mantik. "Merck KGaA sells generics unit to Mylan for $6.6 bln". U.S. Retrieved July 17, 2018.
  138. ^ "Why the CEO Behind the EpiPen Controversy Is on Fortune's Most Powerful Women List". Fortune. Retrieved July 17, 2018.
  139. ^ "As rebel Mylan investors win more backing, CEO Bresch champions her board | FiercePharma". www.fiercepharma.com. Retrieved July 17, 2018.
  140. ^ Daily, Investor's Business (September 22, 2017). "Generic Drug Makers Face Pricing Issues Unlike Other Pharmaceutical Companies | Stock News & Stock Market Analysis - IBD". Investor's Business Daily. Retrieved July 17, 2018. {{cite news}}: |first= has generic name (help)

Media related to Mylan at Wikimedia Commons

  • Business data for Mylan:
Retrieved from "https://en.wikipedia.org/w/index.php?title=Mylan&oldid=880168653"