USFDA grants approval for Cipla's HIV drug

New Delhi: Drug major Cipla on Monday said it has received final approval from the US health regulator for tenofovir disoproxil fumarate tablets, used to treat HIV-1 infections in adults.

Cipla in a BSE filing said it has received final approval from the United States Food and Drug Administration (USFDA) for tenofovir disoproxil fumarate tablets, 300 mg.

These tablets are AB-rated generic equivalents of Gilead Sciences' Viread Tablets, 300 mg, and are indicated in combination with other antiretroviral agents for the treatment of HIV -1 infection in adults and paediatric patients 12 years of age and older.

Citing IMS Health data, the company said Viread Tablets, 300mg, had US sales of approximately USD 725 million for the 12-month period ending November 2017.