Lupin receives approval from U.S. FDA for Fesoterodine Fumarate Extended-Release Tablets Key Points:
- Lupin has received approval from the US FDA for its ANDA, Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg.
- The generic equivalent of Toviaz® Extended-Release Tablets, 4 mg and 8 mg, will be manufactured at Lupin’s facility in Goa, India.
- Fesoterodine Fumarate Extended-Release Tablets had estimated annual sales of $177 million in the US (according to IQVIA MAT September 2022).
Fesoterodine Fumarate Extended-Release Tablets are indicated for the treatment of symptoms of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. The tablets are expected to be launched in the second half of 2022.
Lupin‘s Fesoterodine Fumarate Extended-Release Tablets have an estimated market size of $87.4 million for the twelve months ending November 2022 according to IQVIA. This approval is a significant addition to Lupin’s portfolio of offerings in the urology segment.
Lupin’s development centers have received more than 170 ANDA approvals and have filed over 280 ANDAs since the beginning of the fiscal year. The company’s ANDA pipeline comprises of products in various stages of development, including complex and niche products.
Lupin’s Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, are the AB-rated generic equivalent of Toviaz® Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc. They are indicated for the treatment of symptoms of overactive bladder with urge urinary incontinence, urinary frequency, and urinary urgency. This is Lupin’s sixth approval in the specialty segment in the U.S. in the last few months.
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