Lupin shares in focus after FDA approval for generic HIV tablets
Lupin will remain in focus on Thursday after the drugmaker received approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for HIV tablets emtricitabine and tenofovir alafenamide tablets, 200 mg/25 mg.
«We wish to confirm that the Company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg, to market a generic equivalent of Descovy® Tablets, 200 mg/25 mg of Gilead Sciences, Inc,» Lupin said in an exchange filing.
The approval allows Lupin to market a generic version of Descovy tablets, a product originally developed by Gilead Sciences Inc. Lupin is one of the first companies to receive approval for this generic formulation, making it eligible for 180 days of shared generic exclusivity in the US market. The product will be manufactured at Lupin’s Nagpur facility in India.
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Lupin noted that the approval was not considered material for disclosure under Regulation 30 of SEBI Listing Regulations at the time. The company emphasized its commitment to prompt and transparent communication for any future material developments.
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