Lupin announced that the FDA has approved its Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, to market a generic equivalent of Pfizer Inc.’s Toviaz Extended-Release Tablets, 4 mg and 8 mg.
Lupin’s facility in Goa, India, will produce the product. In the United States, sales of Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg (RLD Toviaz) were estimated to be USD 177 million.