Armstrong Juggles Reformulating Primatene Mist, Pushing To Sell Existing Inventory

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 Inc. expects to relaunch its Primatene Mist asthma inhaler no earlier than 2013, two years after the firm initially planned to have a reformulated product ready and at least a year since the only OTC epinephrine inhaler was pulled from the market.

Armstrong’s parent firm, AmphastarPharmaceuticals Inc., July 18 announced it would submit a new drug application, without chlorofluorocarbon as a propellant...

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