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Aquestive Resubmits Anaphylm for FDA | Business and Finance News

Aquestive Resubmits Anaphylm for FDA | Business and Finance News

Published 2 weeks, 1 day ago
Description

Aquestive Therapeutics is on the verge of resubmitting its Anaphylm epinephrine drug application to the FDA before quarter’s end, armed with new human factors data and promising pharmacokinetic results that show the product performs as well as clinician-administered doses — even when misused. The updated packaging solves key usability issues, positioning Anaphylm to capture market share in the crowded generic epinephrine space by appealing to allergists and payers with real clinical benefits. With launch prep underway, sales materials in development, and recent funding secured, Aquestive is sharpening its focus on FDA approval while managing finances wisely — buoyed by strong revenue from manufacturing and royalties, despite rising expenses.

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