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from: Medscape FDA Approvals: Stalevo CME News Author: Susan Jeffrey Release Date: November 5, 2008; Two New Dosage Strengths of Levodopa, Carbidopa, Entacapone Combination Novartis Pharmaceuticals Corporation announced October 28 approval from the FDA for 2 new dosage strengths of the combination of levodopa, carbidopa, and entacapone, which is indicated for Parkinson's disease patients who experience end-of-dose "wearing off." The new doses are 75 and 125 tablets, which contain, respectively, 18.75 mg of carbidopa, 75 mg levodopa, and 200 mg entacapone; and 31.25 mg carbidopa, 125 mg levodopa, and 200 mg entacapone. The new dosage strengths add to the 50, 100, 150, and 200 tablets that are already available and will provide greater flexibility to the treating physician to customize individual treatment, the company release notes. Combining levodopa, the most widely used agent for treating Parkinson's disease, with enzyme inhibitors carbidopa and entacapone provides greater and more sustained levels of levodopa in the blood, the release states. The combination is approved to substitute immediate-release carbidopa/levodopa and entacapone, previously administered as individual products, or to replace immediate-release carbidopa/levodopa without entacapone, in patients with Parkinson's disease experiencing signs and symptoms of end-of-dose wearing off. The product was developed and manufactured by Orion Corporation and was approved in June 2003. It is marketed in the United States by Novartis Pharmaceuticals Corporation. ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn