Mumbai: Pharma major Cipla Friday said it has received final approval for its Abbreviated New Drug Application (ANDA) for Darifenacin extended-release tablets from the United States Food and Drug Administration (USFDA).
"We have received final approval for ANDA for Darifenacin extended-release tablets, 7.5 mg and 15mg, from USFDA," a company statement said here.
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.
The product will be launched immediately, the release said.
Enablex tablets and generic equivalents had US sales of approximately $85 million for the 12 month period ending June 2016, according to IMS Health.