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.

1 /5 (1 vote)
add to favorites email to friend print save as pdf

Related Stories

US delays decision on first drug to prevent HIV

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

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

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

Health care M&A leads global deal surge

Nov 23, 2014

In a big year for deal making, the health care industry is a standout. Large drugmakers are buying and selling businesses to control costs and deploy surplus cash. A rising stock market, tax strategies and ...

US approves new, hard-to-abuse hydrocodone pill (Update)

Nov 20, 2014

U.S. government health regulators on Thursday approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking ...

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.