FDA delays decision for elvitegravir and cobicistat

On 29 April 2013, a press release from Gilead noted that the FDA would not be approving applications for elvitegravir and cobicistat as separate drugs in their current form.

The press release states that the FDA Complete Response Letters “stated that during recent inspections, deficiencies in documentation and validation of certain quality testing procedures and methods were observed and that Gilead is working with FDA to address the questions raised and move the applications forward.”

These applications have no impact on the previous approval of the four-in-one fixed dose combination Stribild, which contains elvitegravir, cobicistat, tenofovir and FTC. Stribild was approved by the FDA in August 2012 and is expected to receive EU approval as this issue of HTB went to press.

Gilead press statement. Gilead receives complete response letters from U.S. Food and Drug Administration for elvitegravir and cobicistat. (29 April 2013).
http://www.gilead.com/news/press-releases