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HYDERABAD, India &PRINCETON, N.J.--(BUSINESS WIRE)-- Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) announces the launch of Dr. Reddy’s Fesoterodine Fumarate Extended-Release Tablets, a therapeutic generic equivalent to Toviaz® (fesoterodine fumarate) Extended-Release Tablets in the U.S. market following the approval by the U.S. Food and Drug Administration (USFDA).
Alembic Pharmaceuticals on Wednesday said it has received tentative approval from the US health regulator for its generic version of fesoterodine fumarate extended-release tablets, used for overactive bladder in adults with symptoms of urinary incontinence, urgency, and frequency. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for fesoterodine fumarate extended-release tablets is for strengths of 4 mg and 8 mg, the company said in a statement.
Alembic Pharms' Generic Fesoterodine Fumarate Receives Approval in the U.S.