Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa, Levodopa and Entacapone Tablets. The approved strengths include 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg. This product is therapeutically equivalent to Stalevo Tablets, the reference listed drug product. Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. With this approval, Alembic Pharmaceuticals now has a cumulative total of 234 ANDA approvals from the USFDA, comprising 214 final approvals and 20 tentative approvals. The company, established in 1907 and headquartered in India, is a vertically integrated pharmaceutical company with a global presence in manufacturing and marketing generic pharmaceutical products. Its research and manufacturing facilities are approved by major regulatory authorities worldwide.
