Mumbai, December 14, 2017: Pharma Major, Alembic Pharmaceuticals said that it company 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.

Darifenacin extended release tablets is used to treat overactive bladder with symptoms of urinary incontinence, urgency and frequency, company said in afiliung with BSE.

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 USD64 million.

United News of India