Alembic Pharmaceuticals Ltd on Friday said it has received approval from the US health regulator for its generic version of Carbidopa, Levodopa and Entacapone tablets used in treatment of Parkinson’s disease.
The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of Carbidopa, Levodopa and Entacapone tablets of 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; and 50 mg/200 mg/200 mg, Alembic Pharmaceuticals Ltd said in a regulatory filing.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo tablets of similar strengths of Orion Corporation, it added.
Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease, the company said.​Alembic Pharmaceuticals Ltd on Friday said it has received approval from the US health regulator for its generic version of Carbidopa, Levodopa and Entacapone tablets used in treatment of Parkinson’s disease.
The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of Carbidopa, Levodopa and Entacapone tablets of 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; and 50 mg/200 mg/200 mg, Alembic Pharmaceuticals Ltd said in a regulatory filing.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo tablets of similar strengths of Orion Corporation, it added.
Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease, the company said. ​Latest News [ SOBAN NEWS: International and National ]
