Neupro
Generic name: rotigotine
Treatment for: Parkinson's Disease, Restless Legs Syndrome
Schwarz Pharma Re-Submits NDA for Rotigotine in the U.S.
MONHEIM, Germany, January 28, 2005 - Schwarz Pharma announces that it has re-submitted the revised New Drug Application (NDA) for rotigotine (Neupro) transdermal system to the U.S. Food and Drug Administration (FDA) on Friday, January 28, 2005. The FDA had not accepted the application form due to electronic issues.
“Schwarz Pharma worked closely with FDA to address their concerns with the electronic formatting of the NDA,” comments Iris Loew-Friedrich, MD, PhD, Member of the Executive Board Schwarz Pharma AG responsible for research and development. “We believe we have resolved all of the issues in the re-submission.”
Electronic applications for rotigotine transdermal system were submitted to both the U.S. Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) on September 29, 2004. While the application form was accepted by the EMEA, the FDA refused to accept the form due to electronic issues.
Rotigotine has been formulated as a transdermal delivery system, a patch.
Schwarz Pharma AG (headquartered in Monheim, Germany) develops and markets innovative drugs for unmet medical needs with focus on neurology, urology and cardiovascular diseases. The company is investing in development projects targeting diseases such as Parkinson's disease, Restless Legs Syndrome, epilepsy, neuropathic pain, overactive bladder syndrome and benign prostatic hyperplasia. The company has a strong international presence with subsidiaries in Europe, USA and Asia. Shares of Schwarz Pharma AG are traded on the Frankfurt and Duesseldorf stock exchanges.
Posted: January 2005
Related articles
- Neupro Approved by U.S. FDA for Parkinson's Disease and Restless Legs Syndrome - April 3, 2012
- FDA Approves Schwarz Pharma's Neupro (Rotigotine TransdermalSystem) for the Treatment of Early-Stage Parkinson's Disease in USA - May 10, 2007
- Neupro Receives Approvable Letter from FDA for Early Parkinson's Disease in USA - March 1, 2006
- Schwarz Pharma Submits Marketing Applications for its Rotigotine Patch 'Neupro' - September 29, 2004
Neupro (rotigotine) FDA Approval History
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