Lupin has received approval from the United States Food and Drug Administration (USFDA) 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 $177 million in the U.S. (IQVIA MAT September 2022). Earlier, the company had launched novel fixed-dose triple drug combination (FDC) of Indacaterol, Glycopyrronium and Mometasone for managing inadequately controlled asthma amongst patients.
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
