Cipla has received final USFDA approval for its Abbreviated New Drug Application (ANDA) for Darifenacin extended-release tablets. Darifenacin extended-release tablets are AB-rated generic equivalents of Allergan’s Enablex tablets, 7.5 mg and 15 mg, and are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Enablex tablets and generic equivalents had US sales of approximately USD 85 million for the 12 month period ending June 2016, according to IMS Health.
Company Profile : Cipla Ltd
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