New Delhi: Alembic Pharmaceuticals has received US health regulator’s nod for a drug used to treat overactive bladder with symptoms of urinary incontinence, urgency, and frequency.
“The company has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Darifenacin extended-release tablets, 7.5mg and 15mg,” Alembic Pharmaceuticals said in a BSE filing today.
The approved product is equivalent to Enablex of Allergan Pharmaceuticals.
According to IMS December 2016 data, Darifenacin extended-release tablets had an estimated market size of USD 64 million.
The company now has a total of 70 ANDA approvals from the USFDA.