Zydus gets final USFDA Approval for Lubiprostone Capsules
Zydus Lifesciences has received final United States Food and Drug Administration (USFDA) approval to market Lubiprostone Capsules in the strength of 8 mcg and 24 mcg.
Zydus stated that Lubiprostone capsule is indicated to treat certain types of constipation (chronic idiopathic constipation and irritable bowel syndrome with constipation).
The pharma company further stated that the drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).
The group now has 354 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.