Alembic Pharmaceuticals receives USFDA approval for Carbidopa and Levodopa Extended-Release Tablets
Capital MarketAlembic Pharmaceuticals announced that the Company has received approval
from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application
(ANDA) Carbidopa and Levodopa Extended-Release Tablets USP, 2.5 mg/100 mg and 50
mg/200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug
(RLD), Sinemet CR Tablets, 25 mg/100 mg and 50 mg/200 mg, of Merck Sharp & Dohme
Corp. Carbidopa and Levodopa Extended-Release Tablets, USP are indicated in the
treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic
parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
Carbidopa and Levodopa Extended-Release Tablets USP, 25 mg/100 mg and 50 mg/200 mg
have an estimated market size of US$ 24 million for twelve months ending December 2018
according to IQVIA.
Carbidopa and Levodopa Extended-Release Tablets USP, 25 mg/100 mg and 50 mg/200 mg
have an estimated market size of US$ 24 million for twelve months ending December 2018
according to IQVIA.
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