- Senate passes Drug Quality and Security Act
- Reports: ESI may start 'price war' over new hepatitis C drugs
- Gilead's Complera approved for HIV patients already on stable drug regimens
- 21 health industry groups address FDA on proposed changes to generic drug label rules
- USPLabs agrees to recall and destroy dietary supplement following FDA actions
FOSTER CITY, Calif. — Gilead Sciences has refiled an approval application with the Food and Drug Administration for an HIV drug, the drug maker said.
Gilead said it had resubmitted its application for a single-tablet combination of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Johnson & Johnson subsidiary Tibotec Pharmaceuticals’ investigational drug TMC278 (rilpivirine hydrochloride) to treat HIV-1 infection in adults.
Gilead had submitted its application for the drug in November 2010, but the FDA issued a “refuse to file” notification, requesting additional information on the analytical methodology and qualification data used to establish acceptable levels of recently identified degradants related to emtricitabine.