Alembic Pharmaceuticals has received approval from the U.S. Food and Drug Administration (USFDA) for its generic version of Carbidopa, Levodopa and Entacapone tablets, a treatment used in managing Parkinson’s disease.
The approval covers multiple strengths of the generic formulation — 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, and 50 mg/200 mg/200 mg, under an Abbreviated New Drug Application (ANDA), affirming its therapeutic equivalence to the reference product, Stalevo.
The USFDA clearance enables Alembic to market these generics in the United States, a key global pharmaceutical market. Parkinson’s disease is a progressive neurological disorder, and Carbidopa, Levodopa and Entacapone tablets form a combination therapy that helps manage symptoms by improving the availability and effectiveness of levodopa, a primary treatment for the condition.
The approval marks a strategic regulatory milestone for Alembic, enhancing its portfolio of complex generics and strengthening its footprint in the U.S. pharmaceutical segment. The company can now supply the product across allowed dosage strengths and formulations, expanding treatment options for patients and prescribers in the U.S. market.
