Lupin bags tentative USFDA nod for Raltegravir Tablets for HIV-1 infection
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-11-09 05:30 GMT | Update On 2024-11-09 05:45 GMT
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Mumbai: Global pharma major Lupin Limited has announced that the Company has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg, to market a generic equivalent of Isentress HD Tablets, 600 mg of Merck Sharp & Dohme LLC.
Lupin is the exclusive first-to-file for this product and may be eligible to receive a 180-day exclusivity. This product will be manufactured at Lupin’s Nagpur facility in India.
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