FDA Maintains Essential Use Status of Combivent(R) (ipratropium bromide and albuterol sulfate) Inhalation Aerosol Through 2013
April 13 /PRNewswire/ — Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced that the U.S. Food and Drug Administration (FDA) has determined that the “essential use” status of Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol will be effective through December 31, 2013. With this ruling, COMBIVENT will remain on the market and available to the more than two million chronic obstructive pulmonary disease (COPD) patients who rely on it as a bronchodilator.
As a result of the Montreal Protocol, the U.S. Food and Drug Administration (FDA) is phasing-out all remaining prescription oral pressurized metered dose inhalers (MDIs) that use chlorofluorocarbons (CFCs) by removing the “essential use” designation on these products. The FDA’s Final Rule, issued today, determines the timing for this phase-out for the seven remaining MDIs used to treat asthma and COPD.
BIPI has invested more than ten years researching and developing a CFC-free replacement product that will deliver the active ingredients in COMBIVENT and we are committed to working closely with the FDA on its development. The replacement product is in late-stage clinical development and the Company’s goal is that this new product will be available to patients prior to the December 31, 2013 effective date to allow ample time for a seamless transition.
“BIPI requested this status be maintained to allow uninterrupted patient care while we develop a chlorofluorocarbon (CFC)-free COMBIVENT product,” said Christopher Corsico, M.D., MPH, U.S. medical director, Boehringer Ingelheim Pharmaceuticals, Inc. “As a leader in respiratory care, we are dedicated to providing optimal patient care, and are pleased the FDA ruling will allow continued access to COMBIVENT for patients.”
Uninterrupted patient care is important for patients with COPD. This population is particularly vulnerable because nearly 50 percent of patients who use COMBIVENT are 65 or older and 84 percent of patients who use COMBIVENT often have other diseases requiring various treatments to stabilize their health.
read the complete press release and more information about Combivent – click here