Eugia Pharma Specialties Limited, a wholly-owned subsidiary of Aurobindo Pharma Ltd, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Bortezomib for injection.
Bortezomib for Injection is bioequivalent and therapeutically equivalent to the Velcade for Injection of Takeda Pharmaceuticals U.S.A. Inc. The product is being launched immediately.
The approved product has a market size of $1,172 million for the twelve months ending March 2022, according to IQVIA data. 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, the Hyderabad-based Aurobindo said in a release.
Bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma (cancer of plasma cells). It is also used to treat adult patients with mantle cell lymphoma (cancer of lymph nodes).