Subscribe to our Newsletters !!
The life cycle of malaria is a complex process inv
UV-Vis spectroscopy has brought a lot of changes i
Relevant codes should be used when coding fibromya
New literature from Copley Scientific, the worldâ€
Principal Component Analysis (PCA) is a powerful t
It is important to understand that natural remedie
In our cover story, we shine a spotlight on The Magazine
06th January 2023, Mumbai: Alembic Pharmaceuticals Limited (Alembic) 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. (Pfizer). 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. Refer to our label for full indication.
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 179Â ANDA approvals (157 final approvals and 22 tentative approvals) from USFDA.