Copyright © 2007 RhinoCyte, Inc.
Great news!!!!
Second Orphan Drug Designation Granted by FDA
Dec. 31, 2008
RhinoCyte, Inc. just received notification that on December 31, 2008 a second Orphan Drug Designation Application was approved. The following is a section of the FDA’s approval letter:
Highlights from received approval letter.
“Reference is made to your request for orphan-drug designation submitted on behalf of RhinoCyte, Inc. on April 2, 2008, of autologous olfactory neural progenitors (trade name: RhinoCytes™) for “treatment of amyotrophic lateral sclerosis (ALS).” Please also refer to our letters of April 8 and July 17, 2008, and to your submission dated September 29, 2008.
Pursuant to section 526 of the Federal Food, Drug, and Cosmetics 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 amyotrophic lateral sclerosis (ALS).”
Congratulations on obtaining your orphan-drug designation.
Sincerely yours,
Director, Office of Orphan Products Development