Lupine gets USFDA nod to market generic HIV drug – ET HealthWorld

Drug firm Lupine on Monday said it 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, Lupine 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 USD 2.1 billion in the US, it added.

“Emtricitabine and Tenofovir disoproxil Fumarate tablets, 200 mg/300 mg, are indicated in combination with other antiretroviral 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,” Lupine said.

Shares of Lupine Ltd were trading at Rs 1,235 per scrip on BSE, up 0.30 percent from its previous close.


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