Lupin receives tentative U.S. FDA approval for Raltegravir tablets
Express Pharma
NOVEMBER 10, 2024
Lupin, a global pharmaceutical company, has announced its tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg. The approval enables Lupin to market a generic equivalent of Isentress HD Tablets, 600 mg, produced by Merck Sharp & Dohme LLC. Lupin is the exclusive first-to-file applicant for this product, potentially granting it a 180-day exclusivity period in the U.S. market.
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