USA/India: Generics Cipla Receives Final Approval for Generic Enablex Tablets

Editor: Dominik Stephan

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

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(Source: Public Domain / CC0 )

Mumbai/India – Darifenacin Extended-Release Tablets, 7.5 mg and 15 mg, 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. Enablex Tablets and generic equivalents had US sales of approximately $85 million for the 12 month period ending June 2016, according to IMS Health.