Campaign featuring actress Meghann Fahy says "allergy sufferers can relieve their allergy symptoms and be more spontaneous in their romantic pursuits.” Ads launch two months after FDA granted tentative approval for two ANDAs for generic equivalents, indicating approval could come pending resolution of patent litigation.

FDA immediate actions include ensuring providers know they’re required to develop redundancy risk management plans, enhancing inspections of manufacturers, including by expanding and improving training for investigators, and expediting reviews of premarket submissions for new products.

On same day agency published strategy for ensuring formula supply, House Oversight Committee subcommittee members made clear they’re not convinced FDA could prevent repeat of 2022 shortage. Recently resigned FDA food policy chief also has doubts.

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, generics of the Narcan 4-mg nasal spray must transition to OTC, FDA says.

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, other Rx 4-mg nasal sprays, available through abbreviated NDAs as generics of Narcan, must transition to OTC, FDA says.

"You end up with a recipe for maybe there's adulterants in the product. Maybe the product wasn't manufactured according to the spec, so it's misbranded. Worse, there could be adulterants. In some of those ingredients, there's a lot of potential failures,” says Patrick Runkle, senior litigation counsel at DoJ Consumer Protection Branch, during FDL conference.