Alembic Pharmaceuticals receives U.S. FDA approval for Paliperidone extended-release tablets

Alembic Pharmaceuticals (Alembic) announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paliperidone Extended-Release Tablets in strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg. The approved product is therapeutically equivalent to Invega Extended-Release Tablets, the reference listed drug from Janssen Pharmaceuticals, Inc.

Paliperidone extended-release tablets are an atypical antipsychotic used in the treatment of schizophrenia. It is also indicated for the treatment of schizoaffective disorder, either as monotherapy or as an adjunct to mood stabilisers and antidepressants. Further details on the indications are available on the product label.

According to IQVIA, the market size for Paliperidone Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg, is estimated at US$ 48 million for the twelve months ending June 2024.

Alembic has now received a cumulative total of 215 ANDA approvals from the USFDA, including 187 final approvals and 28 tentative approvals.