Cipla gets USFDA nod for overactive bladder treating drug

MUMBAI, September 2016: 
Pharma major Cipla 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. Economic times