Alembic Gets USFDA Approval for Generic Parkinson's Drug

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 generic tablets have been found to be therapeutically equivalent to the reference drug, Stalevo tablets produced by Orion Corporation. Alembic Pharmaceuticals focused on the fact that its generic version has the same effect and safety profile as the branded drug, which is commonly used in treating the symptoms of Parkinson disease.

It is the approval of the Abbreviated New Drug Application (ANDA) of tablets in various strengths, such as 12.5 mg/50mg/200mg, 18.75mg/75mg/200mg, 25mg/100mg/200mg, 31.25mg/125mg/200mg, 37.5mg/150mg/200mg and 50mg/200mg/200mg.

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These are Carbidopa, Levodopa, and Entacapone tablets, which are mainly used to enhance the motor performance of patients with Parkinson, progressive neurological disorder. The USFDA approval will see Alembic diversify its portfolio in the generic drugs market hence making the treatment more affordable to the people fighting the disease.

This is a big step to the company as it keeps solidifying its position in the generic pharma competitive arena.