NEW DELHI: 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.
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 the 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 Rs 635 apiece on BSE.