Zydus Cadila gets tentative US FDA nod for Osimertinib Tablets

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 tumours.

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.