Aurobindo gets U.S. FDA nod for generic of cancer drug

Aurobindo Pharma is introducing Bortezomib for injection, 3.5 mg, its copy of Takeda Pharmaceuticals’ Velcade for Injection 3.5 mg/vial, in the U.S. following receipt of final approval from the U.S. Food and Drug Administration to manufacture and market the drug indicated for treatment of certain cancers.

The approved product has a market size of $1,172 million for the 12 months ending March 2022, the company said citing IQVIA numbers. The product is being introduced immediately, it said in a release announcing wholly owned subsidiary Eugia Pharma Specialties receiving final approval from the regulator.

This is the 136th ANDA, including seven tentative approvals, to be out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products, Aurobindo said.

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), it said.

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