Lupin receives USFDA approval for Fesoterodine Fumarate ER Tablets

Lupin announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, to market a generic equivalent of Toviaz Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc.

The product will be manufactured at Lupin's facility in Goa, India.

Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, (RLD Toviaz) had estimated annual sales of USD 177 million in the U.S. (IQVIA MAT September 2022).

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