NEW DELHI, Feb 2:
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.
“The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Toviaz Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc,” it added.
These tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.
“It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses,” Alembic said.
Citing IQVIA data, the company said fesoterodine fumarate extended-release tablets, 4 mg and 8 mg have an estimated market size of USD 225 million for 12-months ending September 2021.
Alembic said it has received 20 approvals (14 final approvals and 6 tentative approvals) year-to-date and a cumulative total of 159 abbreviated new drug application (ANDA) approvals from USFDA. (PTI)
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