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.
For more information, please visit www.schwarzpharma.com. |