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Primatene Mist Chances To Remain On Market Dwindle With Senate Vote

This article was originally published in The Tan Sheet

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

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.

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

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.

Nephron Launches Asthma Inhaler Into Wide Open OTC Market

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.

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