US delays decision on first drug to prevent HIV

June 9, 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.

Gilead Sciences said Friday the Food and Administration will take an additional three months to review its drug application, after the California company submitted additional materials to the agency earlier this month.

In May, a panel of experts recommended approval of the daily pill Truvada for healthy people who are at high risk of contracting . The group's vote is nonbinding, but the FDA often follows its advice.

Gilead says it submitted updated details on its safety materials for patients and doctors using Truvada. The FDA typically extends its reviews after receiving such information.

Explore further: FDA review favors first drug for HIV prevention (Update)

shares

Related Stories

AIDS fight enters new phase with prevention pill

May 11, 2012

(AP) -- Condoms and other safe-sex practices have accomplished only so much. Now the 30-year battle against AIDS is on the verge of a radical new phase, with the government expected to endorse a once-a-day pill to prevent ...

FDA panel backs first pill to block HIV infection

May 11, 2012

The first drug shown to prevent HIV infection won the endorsement of a panel of federal advisers Thursday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS.

Advocates: HIV prevention pill could save lives

May 11, 2012

(AP) -- A pill to prevent HIV infection is already being given to some healthy people, but without government approval, it remains out of reach and too costly for many who need it.

Recommended for you

Researchers identify drug that alleviates opioid withdrawal

January 30, 2017

Opioid use and abuse is a significant social, health and economic issue in Canada. Researchers at the University of Calgary's Faculty of Veterinary Medicine (UCVM) and Hotchkiss Brain Institute (HBI) have discovered that ...

Detecting counterfeit medicines

January 27, 2017

Bernard Naughton and Dr David Brindley from Oxford University's Saïd Business School and Medical Sciences Division discuss the problems of identifying fake, substandard and expired medicines.

0 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.