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FDA accepts NDAs for Gilead HIV therapies

  • The regulator accepts Gilead Sciences' (GILD) NDAs for cobicistat, a pharmacoenhancing agent that increases blood levels of protease inhibitors atazanavir and darunavir and elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults.
  • After the company submitted its original NDAs in June 2012, the FDA issued CRLs stating it could not approve the products for commercial sale due to deficiencies in documentation and validation of certain quality testing procedures and methods that FDA inspectors observed on site.
  • The firm believes it has effectively addressed the agency's concerns.
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