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

Have a cold? Don't ask your doctor for antibiotics

Nov 26, 2014

Antibiotic resistance is a major threat to public health. Resistance makes it harder for physicians to treat infections and can increase the chance patients will die from an infection. What is more, the treatment ...

Powdered measles vaccine found safe in early clinical trials

Nov 25, 2014

A measles vaccine made of fine dry powder and delivered with a puff of air triggered no adverse side effects in early human testing and it is likely effective, according to a paper to be published November 28 in the journal ...

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.