Zydus Cadila gets tentative USFDA nod to market lung cancer drug

PTI Updated - June 03, 2021 at 12:13 PM.

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

Drug firm Zydus Cadila on Thursday said it has received tentative approval from the US health regulator to market Osimertinib tablets, used to treat lung cancer.

The company has received tentative approval from the US Food and Drug Administration (USFDA) to market Osimertinib tablets in the strengths of 40 mg and 80 mg, Zydus Cadila, part of the Cadila Healthcare group, said in a regulatory filing.

Also read: Cadila to produce up to 30 mn Covid-19 vaccine doses a month

Osimertinib is used to treat lung cancer. Osimertinib works by slowing or stopping the growth of cancer cells.

The company said the newly-approved medication will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad.

The group now has 318 approvals and has so far filed over 400 abbreviated new drug applications since the commencement of the filing process in financial year 2003-04.

Shares of Cadila Healthcare were trading 1.16 per cent higher at ₹635 apiece on the BSE.

Published on June 3, 2021 06:43