Lupin wins USFDA okay for HIV-1 drug Raltegravir

Mumbai: Global pharma major Lupin Limited has announced that the United States Food and Drug Administration (USFDA) has approved the Company's Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg.
Raltegravir Tablets are bioequivalent to Isentress HD Tablets, 600 mg of Merck Sharp & Dohme LLC.
As per the company, Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity.
This product will be manufactured at Lupin’s Nagpur facility in India.
Raltegravir Tablets USP, 600 mg are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients and in pediatric patients weighing at least 40 kg.
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