Alembic Pharma gets USFDA approval for drug to treat overactive bladder

Alembic Pharma gets USFDA approval for drug to treat overactive bladder

The drug is also a therapeutic equivalent of Pfizer's Toviaz extended-release tablets in 4 mg and 8 mg

FPJ Web DeskUpdated: Friday, January 06, 2023, 12:00 PM IST
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Alembic Pharma gets USFDA nod for drug to treat overactive bladder | Image credit: Wikipedia (Representative)

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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