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Niacin/simvastatin

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Niacin/simvastatin
Combination of
NiacinVitamin
SimvastatinStatin
Clinical data
Routes of
administration
Oral
Legal status
Legal status
Identifiers
CAS Number
  (verify)

Niacin/simvastatin (trade name Simcor, by Abbott) is a combination drug consisting of an extended release form of the lipid-lowering drug niacin and the statin drug simvastatin.[1] It is used for the treatment of dyslipidemia. It was approved by the FDA on February 15, 2008.[2] On April 15, 2016, the FDA pulled the approval of niacin and fibrates used in combination with statin drugs, citing growing evidence that the benefits of combining niacin or fibrate drugs with statin drugs to not outweigh the risks, compared to statin therapy alone.[3] This ruling applied to Advicor in addition to Simcor.[3]

References

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  1. ^ Yiu KH, Cheung BM, Tse HF (March 2010). "A new paradigm for managing dyslipidemia with combination therapy: laropiprant + niacin + simvastatin". Expert Opinion on Investigational Drugs. 19 (3): 437–49. doi:10.1517/13543781003623223. PMID 20141348.
  2. ^ "Drugs.com, Abbott Receives FDA Approval for Simcor (Niaspan / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management". Retrieved 2008-03-15.
  3. ^ a b "AbbVie Inc.; Withdrawal of Approval of New Drug Applications for ADVICOR and SIMCOR". U.S. Federal Register. 18 April 2016. Retrieved 17 May 2020.