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Pharmaceuticals / Submissions and Approvals

FDA Approves AUVI-Q Epinephrine Auto-Injector for Infants and Small Children

Nov. 29, 2017

The FDA approved Kaleo’s epinephrine auto-injector, AUVI-Q, at 0.1 mg doses designed for use in infants and small children between 7.5 and 15 kgs. The supplemental NDA was granted priority review by the FDA.

The new auto-injector has a shorter needle length and lower dose of epinephrine than current FDA-approved 0.15 mg and 0.3 mg epinephrine auto-injectors.

The company projects the AUVI-Q 0.1 mg will be available in the first half of 2018.

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