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.

As per the regulatory filing, Fesoterodine Fumarate Extended-Release Tablets is launched to market a generic equivalent of Toviaz Extended-Release Tablets, 4 mg and 8 mg, of Pfizer. The product will be manufactured at Lupin’s facility in Goa.

Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, (RLD Toviaz) had estimated annual sales of $177 million in the US.