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Neupro FDA Approval History

FDA Approved: Yes (First approved May 9, 2007)
Brand name: Neupro
Generic name: rotigotine
Dosage form: Transdermal System
Company: Schwarz Pharma
Treatment for: Parkinson's Disease, Restless Legs Syndrome

Neupro (rotigotine) is a dopamine agonist transdermal system indicated for the treatment of Parkinson’s disease and Restless Legs Syndrome.

Development timeline for Neupro

Apr  3, 2012Approval Neupro Approved by U.S. FDA for Parkinson's Disease and Restless Legs Syndrome
May 10, 2007Approval FDA Approves Schwarz Pharma's Neupro (Rotigotine TransdermalSystem) for the Treatment of Early-Stage Parkinson's Disease in USA
Mar  1, 2006Neupro Receives Approvable Letter from FDA for Early Parkinson's Disease in USA
Jan 28, 2005Schwarz Pharma Re-Submits NDA for Rotigotine in the U.S.
Sep 29, 2004Schwarz Pharma Submits Marketing Applications for its Rotigotine Patch 'Neupro'

Further information

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