Zydus Cadila gets tentative USFDA nod to market anti-cancer drug

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 302 approvals and has so far filed over 390 abbreviated new drug applications since the commencement of the filing process in financial year 2003-04.

Drug firm Zydus Cadila on Thursday said it has received tentative approval from the US health regulator to market anti-cancer drug Palbociclib Capsules. Zydus Cadila has received tentative approval from the US Food and Drug Administration (USFDA) to market Palbociclib Capsules in the strengths of 75 mg, 100 mg, and 125 mg, Zydus Cadila, part of the Cadila Healthcare group, said in a regulatory filing.

Palbociclib is an anti-cancer medicine that interferes with the growth and spread of cancer cells in the body. 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 302 approvals and has so far filed over 390 abbreviated new drug applications since the commencement of the filing process in financial year 2003-04. Shares of Cadila Healthcare were trading 1.07 per cent lower at Rs 379.80 on BSE.