Aurobindo Pharma receives USFDA approval for Lenalidomide Capsules

Aurobindo Pharma announced that its wholly owned subsidiary company, Eugia Pharma Specialities, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Lenalidomide Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg, which is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Revlimid Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg, of Bristol-Myers Squibb Company.

The product is expected to be launched in October 2023 (Volume specific launch). This is the 155th ANDA (including 9 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.

The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone.

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