Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (FDA) 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. (Janssen).
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. Refer label for a detailed indication.
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.
Alembic has a cumulative total of 215 ANDA approvals (187 final approvals and 28 tentative approvals) from US FDA.