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Armstrong Says FDA "Assured" OTC Access Of Reformulated Primatene Mist

This article was originally published in The Tan Sheet

Executive Summary

Armstrong Pharmaceuticals says FDA "assured" the firm that it can sell a proposed reformulated epinephrine inhaler OTC, if approved, despite opponents who say asthma relief is an inappropriate self-medication indication

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Armstrong Pharmaceuticals waits to learn the fate of its recently submitted NDA for reformulated Primatene Mist, and Nephron Pharmaceuticals contests FDA’s September warning that its Asthmanefrin is an unapproved drug.

Asthma Sprays Primatene Mist, Asthmanefrin Await FDA Decisions

Armstrong Pharmaceuticals waits to learn the fate of its recently submitted NDA for reformulated Primatene Mist, and Nephron Pharmaceuticals contests FDA’s September warning that its Asthmanefrin is an unapproved drug.

Asthma Sprays Primatene Mist, Asthmanefrin Await FDA Decisions

Armstrong Pharmaceuticals waits to learn the fate of its recently submitted NDA for reformulated Primatene Mist, and Nephron Pharmaceuticals contests FDA’s September warning that its Asthmanefrin is an unapproved drug.

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