NEW DELHI: Aurobindo Pharma Limited is pleased to announce that its wholly owned subsidiary company, Eugia Pharma Specialties Limited, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Bortezomib for injection, 3.5 mg.
Bortezomib for Injection, 3.5 mg/vial (Single-Dose Vial) to be bioequivalent and therapeutically equivalent to the Velcade for Injection 3.5 mg/vial, of Takeda Pharmaceuticals U.S.A. Inc. The product is being launched immediately. The approved product has a market size of US$ 1172 million for the twelve months ending March 2022, according to IQVIA.
This is the 136th ANDA (including 7 tentative approvals) to be out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
Bortezomib for injection is indicated for the treatment of Adult patients with multiple myeloma (cancer of plasma cells) and Also used to treat adult patients with mantle cell lymphoma (cancer of lymph nodes)