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

FDA review favors first drug for HIV prevention (Update)

May 8, 2012
(AP) -- A pill that has long been used to treat HIV has moved one step closer to becoming the first drug approved to prevent healthy people from becoming infected with the virus that causes AIDS.

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.

US health advisors mull AIDS prevention pill (Update)

May 10, 2012
US health advisers on Thursday urged regulators to approve Truvada, made by Gilead Sciences, as the first preventive pill against HIV/AIDS instead of just a treatment for infected people.

Recommended for you

Drug for spinal muscular atrophy prompts ethical dilemmas, bioethicists say

December 11, 2017
When the Food and Drug Administration approved the first drug for people with spinal muscular atrophy a year ago, clinicians finally had hope for improving the lives of patients with the rare debilitating muscular disease. ...

FDA's program to speed up drug approval shaved nearly a year off the process

December 7, 2017
Speeding the pace at which potentially lifesaving drugs are brought to market was a rallying cry for Donald Trump as a candidate, and is a stated priority of his Food and Drug Administration commissioner, Dr. Scott Gottlieb. ...

Dangers of commonly prescribed painkillers highlighted in study

December 6, 2017
Commonly prescribed painkillers need to be given for shorter periods of time to reduce the risk of obesity and sleep deprivation, a new study has revealed.

Viagra goes generic: Pfizer to launch own little white pill

December 6, 2017
The little blue pill that's helped millions of men in the bedroom is turning white. Drugmaker Pfizer is launching its own cheaper generic version of Viagra rather than lose most sales when the impotence pill gets its first ...

Surgery-related opioid doses can drop dramatically without affecting patients' pain

December 6, 2017
Some surgeons might be able to prescribe a third of opioid painkiller pills that they currently give patients, and not affect their level of post-surgery pain control, a new study suggests.

Four-fold jump in deaths in opioid-driven hospitalizations

December 4, 2017
People who end up in the hospital due to an opioid-related condition are four times more likely to die now than they were in 2000, according to research led by Harvard Medical School and published in the December issue of ...

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.