Zydus Cadila on Thursday said it has got final approval from the US health regulator to market Mesalamine suppositories. The drug is used to treat ulcerative proctitis, a type of bowel disease.
“Zydus Cadila has received final approval from the USFDA to market Mesalamine Suppositories for rectal use...1000 mg,” the drug firm said in a regulatory filing.
Mesalamine Suppositories is an aminosalicylate anti-inflammatory drug and is believed to work by blocking the production of certain natural chemicals that may cause pain and swelling.
This will be manufactured at the group’s topical manufacturing facility at Ahmedabad.
The group now has 280 approvals and has so far filed over 386 ANDAs since the commencement of the filing process in FY 2003-04.
Shares of Cadila Healthcare, the listed entity of the group, were trading down 0.10 per cent at Rs 1,468.95 per scrip on BSE.