Zydus receives final approval from USFDA

Zydus receives final approval from USFDA

Agency News

Mumbai, Jul 3: Pharma major Zydus Cadila has received final approval from the USFDA to market Misoprostol tablets, 100 mcg and 200 mcg.

Misoprostol is used to prevent stomach ulcers in patients taking pain medications especially if the patient is at risk for developing ulcers or has a past history of ulcers, the company said in a filing with BSE. Misoprostol helps to decrease the risk of serious ulcer complications such as bleeding. The drug will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad.

The group now has 268 approvals and has so far filed over 360 ANDAs since the commencement of the filing process in FY 2003-04. (UNI)