Alembic Pharma is in the limelight today. The company announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fesoterodine Fumarate ExtendedRelease Tablets.
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Toviaz Extended-Release Tablets of Pfizer.
These tablets are used for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.
Alembic has received year to date (YTD) 20 approvals (14 final approvals and 6 tentative approvals) and a cumulative total of 159 ANDA approvals (137 final approvals arid 22 tentative approvals) from USFDA.
The stock rose 1.5% to an intraday high at Rs.772.90; its 52-week high is at Rs.1090 and low is at Rs.715.