USFDA Approval of Alembic Pharma's Generic Drug for Schizophrenia
USFDA Approval of Alembic Pharma's Generic Drug
Alembic Pharmaceuticals Ltd has secured final approval from the US Food and Drug Administration (USFDA) for its generic version of Paliperidone extended-release tablets, a medication indicated for the treatment of schizophrenia.
Details of the Approval
- Strengths: The approved Paliperidone extended-release tablets come in strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg.
- ANDAs Approved: This approval falls under the Abbreviated New Drug Application (ANDA) category, which states that the product is therapeutically equivalent to the Reference Listed Drug, Invega extended-release tablets by Janssen Pharmaceuticals, Inc.
Market Impact
According to data from IQVIA, the total market size for Paliperidone extended-release tablets is projected to be around $48 million for the 12 months ending in June 2024.
Alembic Pharma's Achievements
Alembic Pharmaceuticals has achieved a cumulative total of 215 ANDA approvals from the USFDA, which includes 187 final approvals and 28 tentative approvals, underlining the company's growing presence in the pharmaceutical industry.
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.