Aurobindo receives approval for a generic cancer drug from the US approval authority FDA


Aurobindo Pharma is launching Bortezomib for Injection 3.5 mg, its copy of Takeda Pharmaceuticals’ Velcade for Injection 3.5 mg/vial, in the United States after receiving final approval to manufacture and market the medication indicated for the treatment of certain types of cancer.

The approved product has a market size of $1,172 million for the 12 months ended March 2022, the company said, citing IQVIA figures. The product will be launched immediately, according to a press release announcing that wholly-owned subsidiary Eugia Pharma Specialties has received final regulatory approval.

This is the 136th ANDA, including seven preliminary approvals, to manufacture both oral and sterile specialty products at Eugia Pharma Specialty Group (EPSG) facilities, Aurobindo said.

Bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma (cancer of the plasma cells) and is also used to treat adult patients with mantle cell lymphoma (cancer of the lymph nodes), it said.

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