Alembic Pharmaceuticals Ltd on Friday said it has received final approval from the US health regulator for its generic version of Paliperidone extended-release tablets indicated for the treatment of schizophrenia . The approval by the US Food & Drug Administration ( USFDA ) for the Abbreviated New Drug Application (ANDA) Paliperidone extended-release tablets of strengths 1.5 mg, 3 mg, 6 mg, and 9 mg, Alembic Pharmaceuticals said in a regulatory filing.
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, it added. Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for the treatment of schizophrenia and it is also indicated for the treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilisers and/or antidepressants.
Citing IQVIA data, the company said the Paliperidone extended-release tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg have an estimated market size of USD 48 million for 12 months ended June 2024. Alembic Pharma said it has a cumulative total of 215 ANDA approvals (187 final approvals and 28 tentative approvals) from USFDA.
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