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Medicine

FDA rejects two HIV drugs from Gilead Sciences

Monday, April 29, 2013

FOSTER CITY, Calif. — Gilead Sciences Inc. said Monday 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 news release it is working to address the issues raised by the agency. A company representative said in an email that Gilead would not provide further details on the issue.

Elvitegravir and cobicistat are already approved as ingredients in Gilead’s four-in-one HIV pill Stribild, which was approved by FDA in August 2012 for adults who have not yet been treated with anti-HIV drugs.

Gilead a sked the FDA to approve the drugs as stand-alone treatments in June. The company is also seeking approval in Europe.

Its shares fell 19 cents to $51.19 in trading Monday. Its shares peaked for the past year at $55.16 last Tuesday. They traded as low as $24.12 in early June 2012.

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2 more reader comments:

  1. why would the fda approve a cure when they can make more money off of selling pills and making people go thru treatments its clear they dont want to cure hiv they want to profit from it

    Posted on Monday, April 29, 2013 at 12:44pm
  2. An entire Industry relies on NOT curing HIV. Market predictions would miss and shareholders would be angry if HIV was not draining so much money from the dying. It is disgusting the amount of attention Americans pay everything EXCEPT HIV.

    Posted on Monday, April 29, 2013 at 2:25pm