Chelsea Therapeutics Says FDA Advisory Committee To Review NORTHERA

(RTTNews) - Chelsea Therapeutics International, Ltd. (CHTP) announced that the U.S. Food and Drug Administration or FDA has notified the company that the New Drug Application or NDA seeking approval to market NORTHERA, will be reviewed by the Cardiovascular and Renal Drug Advisory Committee or CRDAC. The meeting is tentatively scheduled for January 14, 2014.

Commenting on NORTHERA, the company said it is an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension.

The company noted that the FDA recently assigned to NORTHERA a Prescription Drug User Fee Act or PDUFA goal date of February 14, 2014. NORTHERA was previously granted Orphan Drug Designation and received Fast Track designation from the FDA.

Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need, Chelsea Therapeutics noted.