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ARS Gets Early FDA Approval For Needle-Free Epinephrine

 
• By Joseph Haas

ARS will compete directly with EpiPen and other injectable products with inhaled neffy as the first needle-free epinephrine therapy for severe allergy attacks. EU approval is thought imminent.

Allergies
ARS will take on injectable epinephrine products with FDA-approved neffy • Source: Shutterstock

ARS Pharmaceuticals, Inc. got an ahead-of-schedule US Food and Drug Administration approval for its inhaled formulation of epinephrine for severe allergy attacks on 9 August and is now preparing to launch what one of its executives called “clearly a multibillion market opportunity” during a 12 August call with investors. Called neffy, the product is the first needle-free therapy for type 1 allergic reactions and will compete directly with EpiPen and other injectable epinephrine products, including a generic product from Teva Pharmaceutical Industries Ltd.

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