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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