Alembic Pharmaceuticals on Friday said that it has received final approval from the United States Food and Drug Administration for Fesoterodine Fumarate Extended-Release tablets, which is used in treating overactive bladder in adults.
The final clearance from the US drug regulator has been obtained for the pharma company's Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended-Release tablets, 4mg and 8mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Toviaz Extended-Release Tablets, 4mg and 8mg, of Pfizer Inc., Alembic Pharma said in a filing to the stock exchanges. The company had earlier received tentative approval for this ANDA.
Fesoterodine Fumarate Extended-Release Tablets are used for the treatment of overactive bladder (OAB) in adults with symptoms of urinary incontinence, urgency, and frequency.
According to IQVIA data, Fesoterodine Fumarate Extended-Release Tablets, 4mg and 8mg, have an estimated market size of $177 million for the 12-month period ending September 2022.
So far, Alembic Pharma has a cumulative total of 179 ANDA approvals, including 157 final and 22 tentative clearances, from the USFDA.
Last week, the pharma company received final approval from USFDA for its Fulvestrant injection, which will be used for the treatment of breast cancer.
Alembic Pharma also received the first approval from USFDA for its Jarod Facility’s formulation division IV located in Vadodara district of Gujarat in December 2022.
Alembic Pharma, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Shares of Alembic Pharma are trading 0.5 percent lower at Rs 565.30.
