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OTC Primatene Mist Returns: Market Future Bright After Cloudy NDA History

This article was originally published in The Pink Sheet & The Rose Sheet

Executive Summary

Amphastar has initial inventory on hand of epinephrine inhalation aerosol reformulated with hydrofluoroalkane as a propellant, and expects "almost no costs" for sales of first several hundred thousand units. After two NDAs and two CRLs, firm convinces US FDA consumers can use the product without doctor or pharmacist guidance and understand it is not for ongoing asthma treatment.

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Emergent Expects Moving OTC Naloxone Directions On Package To Sway US FDA Advisory Panel

Based on results from its study for switch NDA, with primary endpoint of users’ success in administering naloxone nasal spray, Emergent changes which DFl panels include the directions. FDA will tell advisory committee the firm has no study data validating effectiveness of changes.

Naloxone OTC Switch NDA Has US FDA Concerned Labeling Will Cause User Error, Delay Delivery

CDER will ask advisory panel “whether additional labeling information might mitigate risk of use errors” for Emergent’s naloxone nasal spray made available OTC and whether results of firm’s human factors study “support that consumers are able to correctly administer nonprescription [naloxone nasal spray] in an emergency situation.”

Primatene Mist First-Quarter Sales Grow 43% As Amphastar Expands Distribution

Sales of Primatene Mist and other higher-margin products drive Amphastar's ifrst-quarter r5esults. The company continues to target a combined market worth around $10.5bn with seven generics in development.

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