Asthma Sprays Primatene Mist, Asthmanefrin Await FDA Decisions
This article was originally published in The Pink Sheet Daily
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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Nephron Pharmaceuticals makes its racepinephrine-containing Asthmanefrin, previously marketed only to health care professionals, available as the only OTC inhaler. The product likely will be alone on the market until Amphastar Pharmaceuticals’ planned launch in 2013 of a reformulated Primatene Mist inhaler.
Armstrong Pharmaceuticals plans to submit in the fourth quarter an NDA to FDA for an OTC asthma inhaler reformulated without chlorofluorocarbon as a propellant. The House Energy and Power Subcommittee proposes allowing the firm to sell its remaining inventory of CFC-containing Primatene Mist.
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