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Cadila Healthcare Ltd (Zydus Cadila), on Wednesday, said it has commercially launched the Mesalamine delayed release tablet USP, for the treatment of mild to moderate ulcerative colitis, in the US market.
The drug, in the strength of 1.2g, will help cure the ailment which affects nearly 700,000 people in the US. Zydus was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda and is currently the only generic available to the patients in the US.
Also, the company said here, it has received the final approval from the USFDA to market Tranexamic acid injection, 1000 mg/10 mL (100 mg/mL) single-dose Vial. Tranexamic belongs to the class of medications called anti-fibrinolytic agents, used to prevent or reduce bleeding in patients with haemophilia undergoing tooth extraction. It will be produced at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.
The group now has more than 130 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.
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