Bazedoxifene
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Bazedoxifene
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| Systematic (IUPAC) name | |
| 1-{4-[2-(azepan-1-yl)ethoxy]benzyl}-2- (4-hydroxyphenyl)-3-methyl-1H-indol-5-ol | |
| Identifiers | |
| CAS number | |
| ATC code | G03 |
| PubChem | |
| Chemical data | |
| Formula | C30H34N2O3 |
| Mol. mass | 470.603 g/mol |
| SMILES | & |
| Pharmacokinetic data | |
| Bioavailability | ? |
| Metabolism | ? |
| Half life | ? |
| Excretion | ? |
| Therapeutic considerations | |
| Pregnancy cat. |
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| Legal status | |
| Routes | ? |
Bazedoxifene is a selective estrogen receptor modulator (SERM), under developed by Wyeth Pharmaceuticals for the prevention and treatment of postmenopausal osteoporosis and the result of an exclusive research collaboration with Ligand Pharmaceuticals.
It is currently in the late phases of review by the United States' Food and Drug Administration. When approved, bazedoxifene is to be sold by Wyeth under the tradename Viviant in the US and Conbriza in the EU. Bazedoxifene's combination with conjugated estrogens, Aprela, is currently undergoing Phase III studies.
Wyeth received an approvable letter for bazedoxifene in late April 2007. The FDA called for final safety and efficacy data from Phase III studies, and acceptable valuation of manufacturing and testing facilities where problems were found earlier in the year. Wyeth was working with the FDA to resolve these issues, and expected an FDA action date at the end of 2007.
As of July 2009, the FDA have not given approval for the use of bazedoxifene in the US. [1]
The drug was approved in the European Union by the European Medicines Agency on April 27, 2009. [2]
[edit] References
- ^ "Drugs@FDA - Drug Names Beginning with "B"" (in English). Food and Drug Administration. 07 July 2009. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchResults_Browse&DrugInitial=B. Retrieved on 2009-07-08.
- ^ "EPARs for authorised medicinal products for human use - Conbriza" (in various). European Medicines Agency. 26 May 2009. http://www.emea.europa.eu/humandocs/Humans/EPAR/conbriza/conbriza.htm. Retrieved on 2009-07-08.
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