Subscribe to our Newsletters !!
Like never seen before, coral reefs across the
Labs today face mounting pressure to cut carbon em
Dr. Mohammed Enayat’s recent testimony on his ag
It is with utmost pride that Microbioz India annou
30th June, 2025 Mumbai: Alembic Pharmaceuticals Li
Since it’s an ingredient in so many foods, you h
In our cover story, we shine a spotlight on “ The Magazine
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, of Otsuka Pharmaceutical Co., Limited (Otsuka). Brexpiprazole Tablets are indicated as an adjunctive therapy to antidepressants for the treatment of major depressive disorder and for treatment of schizophrenia. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses. Refer to our label for full indication.
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of US$ 1.6 billion for twelve months ending Dec 2022 according to IQVIA.
Alembic has a cumulative total of 184 ANDA approvals (160 final approvals and 24 tentative approvals) from USFDA.
