Alembic Pharma bags USFDA nod for Fesoterodine Fumarate ER Tablets to treat overactive bladder

Written by Ruchika Sharma Published On 2023-01-06T12:30:43+05:30 | Updated On 6 Jan 2023 2:13 PM IST

Alembic Pharma bags USFDA nod for Fesoterodine Fumarate ER Tablets to treat overactive bladder

Vadodara: Alembic Pharmaceuticals Limited today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended-Release Tablets, 4 mg, and 8 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Toviaz Extended-Release Tablets, 4 mg, and 8 mg, of Pfizer Inc.

Fesoterodine Fumarate Extended-Release Tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.

Fesoterodine Fumarate Extended-Release Tablets, 4 mg, and 8 mg, have an estimated market size of US$ 177 million for twelve months ending Sep 2022 according to IQVIA.

Alembic had previously received tentative approval for this ANDA. Alembic has a cumulative total of 179 ANDA approvals (157 final approvals and 22 tentative approvals) from USFDA.

Founded in 1907, Alembic Pharmaceuticals Limited is a vertically integrated research, and development pharmaceutical company. The company is headquartered in Vadodara, India. Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.

Read also: Alembic Pharma bags USFDA nod for Hypertension drug Nifedipine Extended Release

Alembic PharmaAlembic Pharma newsUSFDAPfizeroveractive bladderFesoterodine Fumarate Extended Release TabletsToviaz Extended Release Tablets

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751