Ivax Breath-Activated HFA Albuterol Is “Approvable”
This article was originally published in The Pink Sheet Daily
Executive Summary
Ivax' breath-activated hydrofluoroalkane-propelled albuterol is "approvable" at FDA, the company announced July 7
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Ivax' breath-activated hydrofluoroalkane-propelled albuterol is "approvable" at FDA, the company announced July 7. Ivax markets the breath-activated inhaler as Easi-Breathe in Europe for both chlorofluorocarbon and HFA formulations. The NDA was submitted in August 2003. A standard HFA-formulated albuterol inhaler is also approvable at FDA. Ivax says it has responded to the agency's November letter. FDA's Pulmonary-Allergy Drugs Advisory Committee has recommended a phase out of CFC-propelled albuteral devices after 2005 in part to allow Ivax' and Sepracor's products to reach the market before the ban is enacted (1 (Also see "Non-CFC Albuterol Transition Cost Increase Could Affect Patient Access, Cmte. Says" - Pink Sheet, 11 Jun, 2004.)). |