FDA Nixes Two Gilead HIV Drugs As Standalone Treatments in CRL

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