Lupin Limited gets FDA nod for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets

Lupin Limited (Lupin) said it has secured approval for its Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg, from the US Food and Drug Administration (FDA).

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are a generic equivalent of Truvada Tablets, 200 mg/300 mg from Gilead Sciences. They have approval in combination with other antiretroviral agents for treating HIV-1 infection.

Apart from that Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are used for pre-exposure prophylaxis (PrEP) to cut down the risk of sexually acquired HIV-1 infection.

Lupin Limited gets FDA approval for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets. Image courtesy of Gerd Altmann from Pixabay.

As per IQVIA MAT March 2021, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets had estimated annual sales of $2.1 billion in the US.

Lupin Limited will manufacture the Truvada generic at its manufacturing facility in Nagpur, India.

Earlier this month, the Indian pharma company had launched the authorized generic version of Brovana (arformoterol tartrate) Inhalation Solution 15 mcg /2 mL, unit-dose vials, of Sunovion Pharmaceuticals, in the US.