Cancer drug: Aurobindo Pharma arm Eugia Pharma gets USFDA approval for Lenalidomide Capsules
The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone.
Hyderabad: Aurobindo Pharma Limited has announced that its wholly-owned subsidiary company, Eugia Pharma Specialities Limited, 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.
The product 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 155 th ANDA (including 9 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
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The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone.
Medical Dialogues team had earlier reported that Aurobindo's wholly-owned subsidiary company, Eugia Pharma Specialties Limited, had received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Bortezomib for injection, 3.5 mg.
Read also: Aurobindo Pharma arm bags USFDA nod for cancer drug Bortezomib
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 24 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic.
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