Lupin bags tentative USFDA okay for generic HIV Medication
Mumbai: Global pharma major Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Tablets, 800 mg/150 mg/200 mg/10 mg.
This ANDA has been found to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Symtuza Tablets, 800 mg/150 mg/200 mg/10 mg of Janssen Products, LP. Lupin is the exclusive first-to-file for this product.
The product will be manufactured at Lupin’s Nagpur facility in India.
Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Tablets (RLD Symtuza) had estimated annual sales of USD 1,374 million in the U.S. (IQVIA MAT December 2024).
Medical Dialogues team had earlier reported that Lupin had received USFDA approval for its ANDA for Ipratropium Bromide Nasal Solution (Nasal Spray), 0.06%, to market a generic equivalent of Atrovent Nasal Spray, 0.06%, of Boehringer Ingelheim Pharmaceuticals, Inc.
Read also: USFDA nod to Lupin Ipratropium Bromide Nasal Solution for runny nose
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.
Read also: Lupin's Generic Entresto Approved by USFDA, Set to Rival Novartis' Bestseller
