Zydus gets USFDA final approval for Erlotinib Tablets
Ahmedabad: Zydus Cadila has received final approval from the USFDA to market Erlotinib Tablets (US RLD: Tarceva® Tablets), in the strengths of 25 mg, 100 mg, and 150 mg.
Erlotinib is a cancer medicine that interferes with the growth of cancer cells and slows their spread in the body. It is also used to treat non-small cell lung cancer or pancreatic cancer that has spread to other parts of the body (metastatic). Erlotinib is usually given after other cancer medicines have been tried without success.
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, in Ahmedabad.
The group now has 288 approvals and has so far filed over 386 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Cadila is an innovative, global pharmaceutical company headquartered in Ahmedabad, India. The company discovers, develops, manufactures and markets a broad range of healthcare therapies.
The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.