Zydus Cadila gets USFDA nod for cancer drug Ibrutinib

Written by Ruchika Sharma Published On 2021-07-21T15:36:20+05:30 | Updated On 21 July 2021 3:36 PM IST

Zydus Cadila gets USFDA nod for cancer drug Ibrutinib

Ahmedabad: Drugmaker, Zydus Cadila, today announced that the company has received tentative approval from the United States Food & Drug Administration (USFDA) to market Ibrutinib Tablets, in the strengths of 140 mg, 280 mg, 420 mg and 560 mg (US RLD: Imbruvica Tablets).

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.

Zydus Cadila is a global pharmaceutical company headquartered in Ahmedabad, India.

The company discovers, develops, manufactures, and markets a broad range of healthcare therapies.

Read also: Zydus Cadila gets USFDA okay for HIV infection treatment tablets

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751