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Olysio Approval History

FDA Approved: Yes (First approved November 22, 2013)
Brand name: Olysio
Generic name: simeprevir
Dosage form: Capsules
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Hepatitis C

Olysio (simeprevir) is a protease inhibitor for the treatment of chronic hepatitis C virus infection.

Development History and FDA Approval Process for Olysio

DateArticle
Nov  5, 2014Approval FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection
Nov 24, 2013Approval FDA Approves Olysio (simeprevir) for Hepatitis C Virus
Oct 24, 2013FDA Advisory Committee Recommends Approval of Simeprevir for Combination Treatment of Genotype 1 Chronic Hepatitis C in Adult Patients
May 13, 2013U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C
Mar 29, 2013Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C

Further information

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