Alembic Pharmaceuticals announces US FDA tentative approval for antidepressant tablets, Health News, ET HealthWorld
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 the treatment of schizophrenia. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.
According to IQVIA, the market for Brexpiprazole tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg is worth US$ 1.6 billion in the twelve months ending December 2022.
The company claims to have received 184 ANDA approvals from the US FDA (160 final approvals and 24 tentative approvals).
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Thursday, March 9, 2023 at 5:26 am