Alembic gets FDA OK for generic Sinemet
Alembic has received the Food & Drug Administration’s blessing for its generic Sinemet CR (carbidopa and levodopa extended-release tablets). The generic of Merck’s branded product will be available in dosage strengths of 2.5 mg/100 mg and 50 mg/200 mg.
The product indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
The product has a market value of approximately $24 million for the 12 months ending December 2018,
according to IQVIA.
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