Alembic Pharma receives USFDA approval for schizophrenia drug Paliperidone Extended Release
Mumbai: Alembic Pharmaceuticals Limited today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (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..
Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia and it is also indicated for treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants.
Schizophrenia is a chronic and severe mental health disorder that affects how a person thinks, feels, and behaves. People with schizophrenia may seem like they have lost touch with reality, which can be distressing for both the individual and their loved ones. It typically manifests in early adulthood, though symptoms can appear earlier or later in life.
Paliperidone Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg have an estimated market size of US$ 48 million for twelve months ending June 2024 according to IQVIA.
Read also: Alembic Pharma secures USFDA approval for Dabigatran Etexilate Capsules
Alembic has a cumulative total of 215 ANDA approvals (187 final approvals and 28 tentative approvals) from USFDA.
Medical Dialogues team had earlier reported that the company had received tentative approval from the USFDA for its ANDA Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg.
Read also: Alembic Pharma bags USFDA tentative nod for antidepressant drug Brexpiprazole
Headquartered in India, Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. It is 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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