USFDA Gives Nod to Alembic Pharma's Generic Version of Schizophrenia Drug
Alembic Pharmaceuticals Ltd announced that it has secured final approval from the US Food & Drug Administration (USFDA) for its generic drug, Paliperidone extended-release tablets, used in treating schizophrenia. These tablets are offered in strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg.
The ANDAs approved by the USFDA confirm that Alembic's product is therapeutically equivalent to the brand reference drug, Invega extended-release tablets from Janssen Pharmaceuticals, Inc.
Paliperidone is categorized as an atypical antipsychotic agent, also available for managing schizoaffective disorder, either alone or in conjunction with mood stabilizers or antidepressants.
According to IQVIA data, the market for these medications is estimated at $48 million for the year ending in June 2024. With this approval, Alembic now holds a total of 215 ANDA approvals, including 187 final and 28 tentative approvals.
Disclaimer: The information provided on this site is for informational purposes only and is not intended as medical advice. We are not responsible for any actions taken based on the content of this site. Always consult a qualified healthcare provider for medical advice, diagnosis, and treatment. We source our news from reputable sources and provide links to the original articles. We do not endorse or assume responsibility for the accuracy of the information contained in external sources.
This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.