Zydus Cadila gets USFDA approval for colitis drug; margins get a boost

Currently, it sells the authorised generic version of Asacol HD in the US

Ahmedabad-based pharmaceutical giant Cadila Healthcare (Zydus Cadila) has received the final approval from the US drug regulator for its Mesalamine delayed-release tablets that will be manufactured at the Group's formulation facility at Moraiya, which has recently come out from under the US Food and Drug Administration's (USFDA's) scanner. 

Generic Asacol HD has a market size of $400 million approximately and Cadila has approval for the 800 mg tablets. Brokerage firm Edelweiss said that Cadila has entered into a settlement agreement with the innovator (Warner Chilcott). Under the agreement, it is currently selling an authorised generic version (lower margin) of the