Aurobindo Pharma gets USFDA nod for generic cancer drug Bortezomib

New Delhi, May 3

Aurobindo Pharma on Tuesday said its wholly-owned arm Eugia Pharma Specialties Limited has received final approval from the US health regulator to manufacture and market its generic version of Bortezomib for injection used to treat certain types of cancer.

The approval by the US Food and Drug Administration (USFDA) is for single-dose vial of Bortezomib for injection of strength 3.5 miligram per vial, Aurobindo Pharma said in a regulatory filing. 

The product being launched immediately is the generic version of reference listed drug Velcade of Takeda Pharmaceuticals USA Inc.

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

The approved product has a market size of USD 1.172 billion for the 12 months ended March 2022, the company said citing IQVIA data.