Zydus Cadila receives tentative FDA OK for generic Tagrisso

Zydus Cadila has received tentative approval from the Food and Drug Administration for osimertinib tablets in dosage strengths of 40 mg and 80 mg.

The product is the generic of Tagrisso.

Osimertinib is used to treat lung cancer and belongs to a class of drugs known as kinase inhibitors. The medication 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 in SEZ, Ahmedabad.