Copyright © 2007 RhinoCyte, Inc.
Great news!!!!
Orphan Drug Designation Granted by FDA
Highlights from received approval letter.
Feb. 1, 2008
Reference is made to your request for orphan-drug designation submitted on behalf of
Rhinocyte, Inc., dated July 11, 2007, of autologous olfactory neural progenitors
(trade name: Rhinocytes) for "treatment of subacute spinal cord injury." Please also
refer to our letters of July 13 and November 2, 2007, and to your submission dated
December 12, 2007.
Pursuant to section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb),
your request for orphan-drug designation of autologous olfactory neural progenitors
(trade name: Rhinocytes) is granted for treatment of spinal cord injury patients with
ASIA Impairment grades of A, B, or C.
Congratulations on obtaining your orphan-drug designation.
Sincerely yours,
Director, Office of Orphan Products Development