Lupin gets approval for overactive bladder syndrome drug generic

Lupin Limited has secured approval for its abbreviated new drug application (ANDA) for Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg from the United States Food and Drug Administration (FDA).

The approved product of the Indian pharma company is a generic equivalent of Pfizer’s Toviaz Extended-Release Tablets, 4 mg and 8 mg, which is indicated for the treatment of overactive-bladder syndrome.

Lupin will manufacture Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg at its Goa facility.

According to IQVIA MAT September 2022, the estimated annual sales for Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg in the US is 177 million.