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.

Reference

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.