Alembic Pharma bags USFDA final approval for schizophrenia drug Brexpiprazole
Vadodara: Alembic Pharmaceuticals Limited has announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for 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 Company, Ltd.
Brexpiprazole is an atypical antipsychotic used as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults, and also used in treatment of schizophrenia in adults and pediatric patients ages 13 years and older.
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of US$ 2.0 billion for twelve months ending September 2024 according to IQVIA. Alembic has a cumulative total of 220 ANDA approvals (194 final approvals and 26 tentative approvals) from USFDA.
Medical Dialogues team had earlier reported that the Company had received final approval from the USFDA for its ANDA Paliperidone Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Invega Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg, of Janssen Pharmaceuticals, Inc..
Read also: Alembic Pharma receives USFDA approval for schizophrenia drug Paliperidone Extended Release
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company. Headquartered in 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.
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