Announces Submission of Additional Information for NORTHERA(TM) (Droxidopa) NDA
Print
Alert
Chelsea Therapeutics International, Ltd. (MM) (NASDAQ:CHTP)
Historical Stock Chart
1 Month : From Aug 2013 to Sep 2013
Click Here for more Chelsea Therapeutics International, Ltd. (MM) Charts.
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 NORTHERA™ (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.
As previously announced on July 17, 2013, Chelsea received written confirmation from the FDA that the Company's NDA resubmission was deemed to be a complete response to its CRL. The FDA later notified the Company of deficiencies in the NDA that related primarily to the formatting of certain submitted electronic datasets and statistical programs describing the methods used to generate tables and listings. The deficiencies were unrelated to study conduct, interpretability of study results, or validity of study conclusions.
About Northera
