Aurobindo gets tentative approval for generic HIV drug
ROCKVILLE, Md. The Food and Drug Administration has given tentative approval to Aurobindo Pharma's tenofovir disoproxil fumarate tablets in the 300 mg strength, a generic version of an HIV drug, agency records show.
The tablets are a generic version of Gilead Sciences' Viread. Viread, the hepatitis B drug Hepsera (adefovir dipivoxil) and the HIV drug Emtriva (emtricitabine) had combined sales of $245.3 million in fourth quarter of 2008, according to a Gilead statement.
Viread will lose patent protection in 2017, according to the FDA's Orange Book.