News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Chelsea Therapeutics, Inc. (CHTP) Announces Submission of Additional Information for NORTHERA™ (Droxidopa) NDA


8/14/2013 8:25:04 AM

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

CHARLOTTE, N.C., Aug. 14, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that it has submitted additional information to the U.S. Food and Drug Administration (FDA) to resolve certain technical deficiencies in the Company's resubmitted New Drug Application (NDA) for NORTHERAâ„¢ (droxidopa). Pending confirmation by the FDA, the resubmission is expected to be deemed a complete response to the March 28, 2012 Complete Response Letter (CRL) issued by the Agency. A new six month review clock, as specified under the Prescription Drug User Fee Act (PDUFA), will be set from the date of receipt.

Help employers find you! Check out all the jobs and post your resume.

Read at GlobeNewswire

comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES