Eugia Pharma receives US FDA approval for Bortezomib Injection
The approved product has a market size of $1172 million for the twelve months ending March 2022, according to IQVIA
Aurobindo Pharma announced that its wholly-owned subsidiary company, Eugia Pharma Specialties, has received final approval from the US Food & Drug Administration (US FDA) 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 USA. The product is being launched immediately. The approved product has a market size of $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 speciality products.
Bortezomib 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).