USFDA6 Feb 2026, 11:39 am
Alembic Pharmaceuticals Receives USFDA Final Approval for Carbidopa, Levodopa and Entacapone Tablets
AI Summary
Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa, Levodopa and Entacapone Tablets. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets, of Orion Corporation. The tablets are indicated for the treatment of Parkinson's disease. Alembic has a cumulative total of 234 ANDA approvals from USFDA.
Key Highlights
- Alembic Pharmaceuticals Limited receives USFDA Final Approval for Carbidopa, Levodopa and Entacapone Tablets
- The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets, of Orion Corporation
- Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease
- Alembic has a cumulative total of 234 ANDA approvals from USFDA