Aurobindo Pharma Limited’s 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)
– Also used to treat adult patients with mantle cell lymphoma (cancer of lymph nodes)