Generic Treatment for Parkinson Disease Receives FDA Approval
The drug is therapeutically equivalent to Merck’s Sinemet CR Tablets, 25 mg/100 mg and 50 mg/200 mg.
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.
IQVIA estimates the market size for carbidopa and levodopa extended-release tablets USP, 25 mg/100 mg and 50 mg/200 mg to be $24 million for 12 months ending December 2018 according to Alembic.
Alembic submitted an Abbreviated New Drug Application (ANDA) for its Carbidopa and Levodopa Extended-Release Tablets. The company now has 95 ANDA approvals, including 83 final approvals and 12 tentative approvals, from the FDA.
Alembic Pharmaceuticals receives USFDA Approval for Carbidopa and Levodopa Extended-Release Tablets USP, 25 mg/100 mg and 50 mg/200 mg [news release]. Vadodara, India; June 6, 2019: Alembic website. https://www.alembicpharmaceuticals.com/wp-content/uploads/2019/06/Press-Release-USFDA-Approval-Carbidopa-Levodopa-ER-Tab.-June-2019.pdf. Accessed June 9, 2019.