Alembic Pharmaceuticals Limited has strengthened its US generics portfolio with the final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) covering Carbidopa, Levodopa and Entacapone Tablets. The approval spans multiple strengths, including 12.5 mg/50 mg/200 mg up to 50 mg/200 mg/200 mg, enabling Alembic to offer a full range aligned with patient needs.
The approved product is therapeutically equivalent to the reference listed drug Stalevo® Tablets of Orion Corporation. These tablets are indicated for the treatment of Parkinson’s disease, a progressive neurological disorder that affects movement, muscle control, and balance. Patients are advised to refer to the approved prescribing information for detailed indications and usage.
The Carbidopa–Levodopa–Entacapone combination is designed to enhance and prolong the effect of levodopa, the gold-standard therapy for Parkinson’s disease. Levodopa is converted into dopamine in the brain, helping to replenish dopamine levels that are depleted in Parkinson’s disease and improving motor symptoms such as tremors, stiffness, and slowness of movement. Carbidopa inhibits the peripheral breakdown of levodopa before it reaches the brain, allowing lower doses of levodopa to be used while reducing side effects like nausea and vomiting. Entacapone is a catechol-O-methyltransferase (COMT) inhibitor that further extends levodopa’s duration of action by preventing its metabolism, helping to reduce “wearing-off” symptoms between doses.
Together, this triple-drug regimen offers more stable symptom control for patients experiencing fluctuations with levodopa therapy alone.
With this approval, Alembic continues to expand its presence in the regulated US market. The company now holds a cumulative total of 234 ANDA approvals from the USFDA, comprising 214 final approvals and 20 tentative approvals, underscoring its consistent execution and focus on complex and value-added generics.
