Search results
Results From The WOW.Com Content Network
Elbasvir/grazoprevir, sold under the brand name Zepatier, is a fixed-dose combination for the treatment of hepatitis C, containing elbasvir (an inhibitor of hepatitis C virus's NS5A protein) and grazoprevir (an NS3/4A inhibitor). It is used to treat chronic hepatitis C virus (HCV) genotypes 1 or 4 infection in both treatment-naïve and ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
The agency's decision has no impact on the approved indication for the vaccine in the U.S. for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of ...
Combined hepatitis A and B vaccine, is used to provide protection against hepatitis A and hepatitis B. [3] [7] It is given by injection into muscle.[8]It is used in areas where hepatitis A and B are endemic, for travelers, people with hepatitis C or chronic liver disease, and those at high risk of sexually transmitted diseases.
Robert F. Kennedy Jr.'s personal attorney previously petitioned the Food and Drug Administration to revoke its approval of a polio vaccine, highlighting an influential Kennedy ally who, sources ...
For premium support please call: 800-290-4726 more ways to reach us
Sofosbuvir/velpatasvir was developed by the pharmaceutical company Gilead Sciences and approved by the U.S. Food and Drug Administration (FDA) in June 2016. [13] In the European Union it was approved in July 2016, for the treatment of chronic hepatitis C virus infection in adults.