Alembic Pharmaceuticals Limited today 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. Alembic now has a total of 95 ANDA approvals (83 final approvals and 12 tentative approvals) from USFDA.