MedGuide=REMS? Not Always

 
• By Michael McCaughan

FDA and stakeholders agree that MedGuide-only REMS are more trouble than they are worth. The agency has already told two sponsors that they don't need a REMS even though they need a MedGuide--but only because there are other products in the class that don't have REMS.

When FDA approved AstraZeneca PLC/Pozen Inc.'s naproxen/esomeprazole formulation Vimovo on April 30, the approved indications were only for use in arthritis and related indications; this formulation isn't intended to for relief of headaches, like the OTC naproxen brand Aleve.

Still, while Vimovo may not be approved for headache relief, FDA's approval letter prevented one headache for the sponsor: the agency told the companies that they would not need a...

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