Zydus Cadila has informed that the USFDA has given final approval to market Mesalamine Delayed- Release Tablets USP, 1.2 g in the US market. Zydus Cadila was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda® (mesalamine).
Lialda® is indicated for the treatment of mild to moderate ulcerative colitis. Ulcerative colitis is a chronic inflammatory bowel disease that affects approximately 700,000 people in the United States. The generic version of Lialda® (mesalamine) will be produced at Moraiya Plant located at Ahmedabad. The estimated brand sales for Mesalamine Delayed-Release Tablets USP, 1.2 g is US $ 1.145 billion as per IMS MAT April 2017.
The group now has more than 115 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.
Shares of CADILA HEALTHCARE LTD. was last trading in BSE at Rs.537.25 as compared to the previous close of Rs. 490.4. The total numb er of shares traded during the day was 1211121 in over 20166 trades.
The stock hit an intraday high of Rs. 542.4 and intraday low of 491.05. The net turnover during the day was Rs. 638229468.
Source: Zydus Cadila gets USFDA final approval for Mesalamine Delayed-Release Tablets USP, 1.2 g
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