FDA issues Flonase, Nasonex lettersThe FDA's Division of Drug Marketing, Advertising and Communications has issued untitled letters of violation to Schering-Plough for its Nasonex nasal spray, and to GlaxoSmithKline for its Flonase nasal spray, concerning detail aids used by reps for both brands.
The agency said the sales aids were false and misleading in making superiority claims over each other.
GSK stopped detailing for Flonase in 2006 when the drug went generic. The company is expected to take into account the FDA guidance to develop promotional material for its Flonase follow-on Veramyst.
Schering-Plough spokeswoman Mary-Fran Faraji told The Wall Street Journal the company had already replaced the Nasonex promotional materials. After receiving the FDA letter, the company told its sales reps not to use the old selling aids anymore. The company responded to FDA in writing and is working with the agency to resolve its concerns, she said.