USFDA gives nod to these companies for Bortezomib for injection

Bortezomib for injection is used to treat certain types of cancer such as multiple myeloma and mantle cell lymphoma.

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USFDA Approval
USFDA Approval

Last Updated on October 11, 2024 by The Health Master

Zudus

Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) to market Bortezomib for injection, 3.5 mg/vial, single-dose vial, a company statement notified.

Bortezomib for injection is used to treat certain types of cancer such as multiple myeloma and mantle cell lymphoma.

The medication works by slowing or stopping the growth of cancer cells. The drug will be manufactured at Zydus Hospira, the statement added.

Aurobindo

Aurobindo Pharma on Tuesday said its wholly-owned arm Eugia Pharma Specialties Ltd 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 mg/vial, Aurobindo Pharma said in a regulatory filing. The product is the generic version of reference listed drug Velcade of Takeda Pharmaceuticals USA Inc.

The product is being launched immediately, it added.

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.

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