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Pharmaceuticals
FDA Delays Approvals For Gilead Sciences
by Ann M. Thayer
May 6, 2013
| A version of this story appeared in
Volume 91, Issue 18
FDA has told Gilead Sciences that it won’t approve elvitegravir and cobicistat, two HIV drugs the company hopes to launch as individual products. Both drugs are components of Gilead’s Stribild, a single-tablet, four-drug combination that patients take once daily. Although FDA approved Stribild in August 2012 and the company can still sell it, the agency found deficiencies in quality-testing procedures and methods during recent inspections of manufacturing processes for elvitegravir and cobicistat. Gilead says it is working with FDA to address the problems.
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