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Armstrong Juggles Reformulating Primatene Mist, Pushing To Sell Existing Inventory

 
• By Lisa Gillespie

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 for the product, to FDA in the fourth quarter this...

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