India, Feb. 6 -- Alembic Pharmaceuticals Limited on Friday announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa, Levodopa and Entacapone Tablets across multiple strengths.
The approved ANDA covers tablet strengths of 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. The product is therapeutically equivalent to the reference listed drug, Stalevo tablets, originally developed by Orion Corporation.
Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease, as per approved labelling.
With this approval, Alembic Ph...