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Cipla gets final US FDA approval for generic Enablex tablets

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Cipla has received final approval for its ANDA for darifenacin extended-release tablets, 7.5mg and 15mg, from the US FDA.

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Darifenacin extended-release tablets, 7.5mg and 15mg, are AB-rated generic equivalents of Allergan’s Enablex tablets, 7.5mg and 15mg, 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.

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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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