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Alembic Pharmaceuticals has received approval from the US Food and Drug Administration, to treat overreactive bladder with symptoms of urinary incontinence, urgency and frequency.
In a BSE filing Alembic Pharma stated, “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.”
The product which has received approval is equivalent to Enablex of Allergan Pharmaceuticals. Further, Alembic now has a total of 70 ANDA approvals from the USFDA.
