Zdrowie i gospodarka · 09/02/2011

FDA Clears Way for Generic Dexamethasone Topical Aerosol Applications

The FDA has determined that DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, and AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%, were not withdrawn from sale due to safety or effectiveness concerns, paving the way for generic applications. However, applicants may face challenges in obtaining these products for bioequivalence testing, and should contact the Office of Generic Drugs for guidance.