Generic Treatment for Parkinson Disease Receives FDA Approval – APhA submits compounding comments to FDA. – (866) 348-2889.
Alembic Pharmaceuticals has received FDA approval for its Carbidopa and Levodopa Extended-Release Tablets USP, 2.5 mg/100 mg and 50 mg/200 mg, according to the company. The drug is therapeutically equivalent to Merck’s Sinemet CR Tablets, 25 mg/100 mg and 50 mg/200 mg.
Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.