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Home » FDA Nixes Two Gilead HIV Drugs As Standalone Treatments in CRL
FDA Nixes Two Gilead HIV Drugs As Standalone Treatments in CRL
May 8, 2013
Gilead’s efforts to win approval of two HIV medications — already marketed as part of its quad combo Stribild — came to a halt April 29. Citing “deficiencies in documentation and validation of certain quality testing procedures and methods,” the FDA issued the California drugmaker a complete response letter for its HIV drugs elvitegravir and cobicistat.
Washington Drug Letter
Washington Drug Letter
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