The FDA has approved Schwarz Pharma's Parkinson's disease patch Neupro for the early stages of the disease.
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The once-daily transdermal patch Neupro will be available in the US in three strengths (2mg/24 hours; 4mg/24 hours; and 6mg/24 hours). Neupro contains rotigotine, which is designed to mimic the action of dopamine, a naturally-produced neurotransmitter crucial for proper motor functioning.
Chief scientific officer, Iris Loew-Friedrich, said: “This is an important step forward for the patients suffering from Parkinson’s disease. Following approval and launch within Europe, Neupro will now be available for patients in the USA. We intend to submit a supplemental New Drug Application for the treatment of advanced Parkinson’s disease to the FDA by the end of 2007.”
Rotigotine transdermal system is approved in Europe for the treatment of patients with early and advanced Parkinson’s disease in combination with levodopa, and has been available in the EU since March 2006.
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