Zydus Cadila gets tentative approval to market Osimertinib Tablets

03 Jun 2021 Evaluate

Zydus Cadila has received tentative approval from the USFDA to market Osimertinib Tablets in the strengths of 40 mg and 80 mg (US RLD: Tagrisso Tablets). Osimertinib is used to treat lung cancer. It belongs to a class of drugs known as kinase inhibitors. Osimertinib works by slowing or stopping the growth of cancer cells. It binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors.

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad. The group now has 318 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

Cadila Healthcare is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.

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