Alembic Pharmaceuticals Ltd has received the final abbreviated new drug approval from the US Food and Drug Administration for Fesoterodine Fumarate extended-release tablets, the company said in an exchange filing.
Used to treat overactive bladder in adults, the company received the approval on Fesoterodine Fumarate's 4 mg and 8 mg doses.
The drug is also a therapeutic equivalent of Pfizer's Toviaz extended-release tablets in 4 mg and 8 mg, Alembic Pharmaceuticals said.
Fesoterodine Fumarate extended-release tablets of 4 mg and 8 mg have an expected market size of $177 million, according to IQVIA statistics for the twelve months ending September 2022.
A total of 179 abbreviated new medication approvals, including 157 and 22 tentative approvals from the US FDA, were reported by the business.
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