Zydus Cadila gets USFDA nod for Ibrutinib tablets

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

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Medicine Tablet
Picture: Pixabay

Last Updated on July 22, 2021 by The Health Master

Zydus Cadila has received tentative approval from the US Food and Drug Administration (USFDA) to market Ibrutinib tablets, in the strengths of 140 mg, 280 mg, 420 mg and 560 mg.

Ibrutinib belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia / small lymphocytic lymphoma, and Waldenstrom’s macroglobulinemia.

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.

The group now has 319 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

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