Aurobindo Pharma arm bags USFDA nod for cancer drug Bortezomib

Hyderabad: Drugmaker, Aurobindo Pharma Limited, has recently announced 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.

Read also: Aurobindo Pharma acquires domestic formulation business of Veritaz for Rs 171 crore

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)

Eugia Pharma Specialities Ltd. had earlier received a 505(b)(2) NDA approval from the U.S.Food & Drug Administration (USFDA) for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vials. 

Read also: Aurobindo Pharma Arm Gets USFDA Okay For Cyclophosphamide Injection

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 155 countries.

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