Federal Register Notice: FDA has determined that Decaspray (dexamethasone) topical aerosol, 0.04%, and Aeroseb-Dex (dexamethasone) topical aerosol, 0.01%, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs for dexamethasone topical aerosol, 0.04% and 0.01%, if all other legal and regulatory requirements are met. Future applicants are advised that they may not be able to obtain Decaspray or Aeroseb-Dex for bioequivalence testing because the products have not been commercially available for a number of years. Such ANDA applicants not able to obtain the products should contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and same therapeutic effect. To view this notice, click here.