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Article: FDA issues approvable letter for Albuterol HFA in breath-activated inhaler.
- Article from:
- Obesity, Fitness & Wellness Week
- Article date:
- July 31, 2004
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2004 JUL 31 - (NewsRx.com & NewsRx.net) -- IVAX Corporation (IVX) has received an approvable letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for albuterol sulfate using non-ozone-depleting, CFC-free propellant in IVAX' patented breath-activated aerosol inhaler.
Albuterol, a beta-agonist bronchodilator, is the primary rescue medicine for the relief of asthma symptoms. Over 90% of the more than 50 million albuterol inhalers sold in the U.S. last year contained chlorofluorocarbon (CFC) propellants, which are expected to be eventually removed from the market due to concern about ozone depletion.
On June 16, 2004, ...