Mylan Inc announces receipt of FDA approval for generic Parcopa ODT for Parkinson's disease
Tue. September 23, 2008; Posted: 04:29 AM
Sep 23, 2008 (M2 EQUITYBITES via COMTEX) --
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PowerRating -- Mylan Inc (NYSE: MYL), a generic and specialty pharmaceutical company,
said on 22 September that its subsidiary Mylan Pharmaceuticals Inc has
received final approval from the US Food and Drug Administration (FDA)
for its Abbreviated New Drug Application (ANDA) for 10 mg/100 mg, 25
mg/100 mg and 25 mg/250 mg Carbidopa and Levodopa Orally Disintegrating
Tablets (ODT), for use in the treatment of idiopathic Parkinson's
disease.
According to the company, Carbidopa and Levodopa ODT are the generic
version of Schwarz Pharma's Parcopa ODT.
The product reported annual US sales of approximately USD7.4m for the
12 months ending 30 June 2008, for the noted strengths, according to
IMS Health.
Mylan said that Carbidopa and Levodopa ODT will be its first generic
version tobe marketed.
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