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FDA Grants Final Approval for SCHWARZ PHARMA's Parcopa
- Aug 30 2004
SCHWARZ PHARMA has received final approval from the U.S. Food and Drug Administration (FDA) to market Parcopa [Trademark] (carbidopa-levodopa orally disintegrating tablets). Parcopa's unique formulation dissolves rapidly in the mouth, thereby providing patients suffering from Parkinson's disease with improved access to their medication.
"Our recent clinical study showed that in comparison with their current tablets, Parkinson's patients had a clear preference for Parcopa for several specific reasons associated with the daily challenges of managing this complex disease. We are very happy that we can now offer this new treatment option, and we are already in the process of launching the product", says Klaus Veitinger, M.D., Member of the Executive Board SCHWARZ PHARMA AG. "Parcopa will establish our presence in the neurology offices and help prepare the launch platform for our future products for Parkinson's disease and other neurological disorders."
Parkinson's disease patients experience symptoms such as morning rigidity or "off periods" - episodes of decreased movement or complete immobility - that can make dosing problematic. Unlike conventional carbidopa-levodopa, Parcopa dissolves in the mouth using RapiTab [Trademark] technology to deliver medicine without the need for water, providing patients with a convenient means to take their medication.
Source Date: Aug 30 2004
Source Publication: SCHWARZ PHARMA