Alembic Pharmaceuticals has secured USFDA final approval for its Abbreviated New Drug Application (ANDA) for Carbidopa, Levodopa, and Entacapone Tablets. The approved tablets, available in multiple strengths, are therapeutically equivalent to Stalevo Tablets. These tablets are indicated for the treatment of Parkinson’s disease, marking a significant milestone for Alembic and providing a cost-effective alternative for patients. This approval brings Alembic’s total ANDA approvals to 234.
USFDA Approval for Parkinson’s Tablets
Alembic Pharmaceuticals announced on February 6th, 2026, that it has received final approval from the US Food & Drug Administration (USFDA) for its Carbidopa, Levodopa and Entacapone Tablets. This Abbreviated New Drug Application (ANDA) covers multiple strengths:
- 12.5 mg/50 mg/200 mg
- 18.75 mg/75 mg/200 mg
- 25 mg/100 mg/200 mg
- 31.25 mg/125 mg/200 mg
- 37.5 mg/150 mg/200 mg
- 50 mg/200 mg/200 mg
These tablets are a therapeutically equivalent generic version of Stalevo Tablets, which are used in the treatment of Parkinson’s disease.
Impact and Portfolio Expansion
With this approval, Alembic Pharmaceuticals now has a cumulative total of 234 ANDA approvals from the USFDA, consisting of 214 final approvals and 20 tentative approvals. This further strengthens Alembic’s presence in the US market and reinforces its commitment to providing affordable and accessible healthcare solutions.
About Carbidopa, Levodopa, and Entacapone Tablets
Carbidopa, levodopa, and entacapone tablets are indicated for the treatment of Parkinson’s disease. Refer to product labeling for detailed information on usage and safety.
Source: BSE
