Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir
Cinnamon Girl said
Apr 9, 2013
Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C
-- Sofosbuvir Would Form Basis of First All-Oral Regimen for HCV Genotype 2 and 3 Patients, and Interferon-Sparing Regimen for Genotype 1 Patients --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 8, 2013-- Gilead Sciences today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection. The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naļve patients with genotype 1, 4, 5 and 6 HCV infection.
Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C
-- Sofosbuvir Would Form Basis of First All-Oral Regimen for HCV Genotype 2 and 3 Patients, and Interferon-Sparing Regimen for Genotype 1 Patients --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 8, 2013-- Gilead Sciences today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection. The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naļve patients with genotype 1, 4, 5 and 6 HCV infection.
Full article...
http://hcvadvocate.blogspot.ca/2013/04/gilead-submits-new-drug-application-to.html