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Sun Pharma gets USFDA nod to market generic medication

The company has received final approval from the US Food and Drug Administration (USFDA) for the generic lenalidomide capsules in multiple strengths, Sun Pharma said in a statement.

February 10, 2023 / 13:07 IST
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Sun Pharmaceutical Industries on Friday said its subsidiary has received approval from the US health regulator to market a generic medication used in the treatment of multiple myeloma.

The company has received final approval from the US Food and Drug Administration (USFDA) for the generic lenalidomide capsules in multiple strengths, Sun Pharma said in a statement.

In June 2021, Sun Pharma entered into a settlement with Celgene Corporation (Celgene) to resolve the patent litigation regarding its generic lenalidomide capsules.

Under the terms of this settlement, Celgene granted Sun Pharma a license to patents required to manufacture and sell certain limited quantities of generic lenalidomide capsules in the US, beginning sometime after March 2022.

In addition, the license allows Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026.

Shares of Sun Pharma were trading 0.48 percent down at Rs 1,002 apiece on the BSE.

PTI
first published: Feb 10, 2023 01:09 pm

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