Drug firm Lupin Ltd on Wednesday (December 18) announced that it has 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.
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“…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 a regulatory 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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The company stated that under Regulation 30 of the SEBI Listing Regulations, the approval was not deemed material for stock exchange disclosure at the time. Lupin reaffirmed its commitment to making prompt disclosures whenever a material event arises.
“Further, the company is not aware of any other event or information that was required to be announced and has not been announced in terms of the SEBI Listing Regulations. The company makes prompt disclosures, as and when any event or information is considered material or warrants such disclosure under the said Regulations and shall continue to do so,” it added.
Shares of Lupin Ltd ended at ₹2,099.70, up by ₹53.80, or 2.63%, on the BSE.
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(Edited by : Shoma Bhattacharjee)
