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
You may also be interested in...
Ivax CFC-Free Albuterol Will Launch In Fourth Quarter
FDA cleared the NDA for the asthma treatment Oct. 29. Ivax’ CFC-free albuterol inhaler offers an alternative to GlaxoSmithKline’s Ventolin HFA in advance of an FDA final rule that is expected to remove CFC-propelled albuterol from the market in 2006.
Ivax CFC-Free Albuterol Will Launch In Fourth Quarter
FDA cleared the NDA for the asthma treatment Oct. 29. Ivax’ CFC-free albuterol inhaler offers an alternative to GlaxoSmithKline’s Ventolin HFA in advance of an FDA final rule that is expected to remove CFC-propelled albuterol from the market in 2006.
Non-CFC Albuterol Transition Cost Increase Could Affect Patient Access, Cmte. Says
Low-income patients will bear the burden of increased costs of transition from CFC albuterol to non-ozone depleting formulations, committee member says. GSK sampling and patient assistance programs are aimed at lessening burden. Longer transition period could allow introduction of competitors/generics, committee member suggests.