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Cipla receives final approval for generic Enablex tablets

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These tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency

Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Darifenacin extended-release tablets, 7.5 mg and 15 mg, from the United States Food and Drug Administration (USFDA).

Darifenacin extended-release tablets, 7.5 mg and 15 mg, 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. The product will be launched immediately.

Enablex tablets and generic equivalents had US sales of approximately $85 million for the 12 month period ending June 2016, according to IMS Health.

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