Lupin gets USFDA nod to market generic HIV drug

Lupin has received a nod from the US health regulator to market generic emtricitabine and tenofovir disoproxil fumarate tablets used for the treatment of human immunodeficiency virus (HIV)-1 infection in the American market.

The company has received approval from the United States Food and Drug Administration (USFDA) to market its emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, Lupin said in a regulatory filing.

The product is a generic version of Gilead Sciences Inc’s truvada tablets in the same strength, it added.

The product will be manufactured at the company’s facility in Nagpur, the filing said.

Emtricitabine and tenofovir disoproxil fumarate tablets had estimated annual sales of $2.1 billion in the US, it added.

“Emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, are indicated in combination with other anti-retroviral agents for the treatment of HIV-1 infection. It is also used for pre-exposure prophylaxis to reduce the risk of sexually-acquired HIV-1 infection,” Lupin said.