Lupin receives approval from U.S. FDA for Fesoterodine Fumarate Extended-Release Tablets

Global pharma major Lupin Limited (Lupin) today 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).

Shares of Lupin Limited was last trading in BSE at Rs. 738.45 as compared to the previous close of Rs. 742.90. The total number of shares traded during the day was 31893 in over 1479 trades.

The stock hit an intraday high of Rs. 746.90 and intraday low of 734.10. The net turnover during the day was Rs. 23574605.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 USFDA ANDA Approval FesoterodineFumarate ExtendedReleaseTablets