Eugia Pharma receives USFDA approval for Lenalidomide capsules
New Delhi: Aurobindo Pharmaceuticals on Wednesday said its wholly-owned subsidiary firm Eugia Pharma Specialties has received final approval from the US Food and Drug Administration (USFDAto manufacture and market Lenalidomide Capsules used to treat multiple myeloma.
Lenalidomide Capsules 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg are 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 firm said in a statement.
The product is expected to be launched in October 2023.
“This is the 155th ANDA (including 9 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products,” it said.
“The approved product is indicated for the treatment of adult patients with multiple myeloma, in combination with Dexamethasone.”
Hyderabad-headquartered Aurobindo Pharma manufactures a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.