FDA rejects two HIV drugs from Gilead Sciences

Gilead Sciences Inc. says that the Food and Drug Administration rejected two marketing applications for HIV treatments, citing quality control problems at the company's manufacturing facilities.

The FDA informed the company in a letter that it cannot approve its HIV pills elvitegravir and cobicistat for use in managing the virus that causes AIDS.

The agency noted that in recent inspections regulators have found problems with documentations and quality testing at Gilead Sciences' facilities.

The company said in a release it is working to address the issues raised by the agency.

Related Stories

US delays decision on first drug to prevent HIV

date Jun 09, 2012

(AP) — Drugmaker Gilead Sciences Inc. says federal health regulators have delayed a decision on whether to approve its drug Truvada as the first pill that prevents HIV infection.

Oral pill trial to halt HIV in women is stopped

date Apr 19, 2011

A trial of an oral pill aimed at preventing HIV infection in African women has been halted due to poor results, the trial operator Family Health International announced this week.

FDA panel backs first rapid, take home HIV test

date May 15, 2012

(AP) -- A panel of HIV specialists is recommending that U.S. regulators approve the first over-the-counter HIV test designed to quickly return a result in the privacy of a person's own home, a new option which could expand ...

Recommended for you

Teva to lift bid for Mylan: report

date 22 hours ago

Israeli pharmaceutical giant Teva plans to increase its bid for rival Mylan and could announce the move as soon as this week, according to a US media report Monday.

Vaccine for West Nile Virus enters human clinical trials

date Jul 06, 2015

A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes ...

FDA clears drug for leading form of cystic fibrosis

date Jul 02, 2015

Federal health officials have approved a new combination drug for the most common form of cystic fibrosis, the debilitating inherited disease that causes internal mucus buildup, lung infections and early death. But it will ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.