Is Sofosbuvir FDA approved?
Is Sofosbuvir FDA approved?
U.S. Food and Drug Administration Approves Gilead’s Sovaldi™ (Sofosbuvir) for the Treatment of Chronic Hepatitis C. Sovaldi in combination with ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are interferon ineligible.
When did Sofosbuvir get FDA approval?
Development Timeline for Sovaldi
| Date | Article |
|---|---|
| Apr 7, 2017 | Approval FDA Approves Sovaldi (sofosbuvir) for Chronic Hepatitis C Infection in Pediatric Patients 12 Years and Older |
| Dec 6, 2013 | Approval FDA Approves Sovaldi for Chronic Hepatitis C |
What is the brand name for Sofosbuvir?
Sofosbuvir, sold under the brand name Sovaldi among others, is a medication used to treat hepatitis C. It is taken by mouth.
Is Epclusa FDA approved?
On June 28, 2016, the U.S. Food and Drug Administration (FDA) approved EPCLUSA® (a combination tablet that includes Sofosbuvir and Velpatasvir) for the treatment of adult patients with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis, with compensated cirrhosis, or with decompensated …
Is Harvoni FDA approved?
(Nasdaq: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Harvoni® (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV.
When was Harvoni approved?
Approval Date: 10/10/2014.
Who manufactures sofosbuvir?
About Gilead Sciences, Inc. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California .
Is sofosbuvir generic?
There is currently no generic for Sovaldi (sofosbuvir), so it can be expensive, even with insurance.
Where is Epclusa manufactured?
Epclusa is manufactured and marketed by Gilead Sciences, Inc., of Foster City, California.
When did Harvoni get FDA approval?
Is Sovaldi FDA approved?
Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection. On November 22, the FDA approved Olysio (simeprevir). Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.
