FDA, on Tuesday, announced that it would phase out the use of seven asthma and chronic obstructive pulmonary disease inhalers to keep in check with regulations banning devices containing chlorofluorocarbons (CFCs).
Four of the devices have already been discontinued, and the manufacturers of the remaining devices will have to find suitable replacements in the very near future. However, the companies that still have the inhalers on the market (albeit for limited time) are making a point of advising consumers and physicians that they should wait until the new inhalers are in place before stopping treatment.
Boehringer Ingelheim (BI), in particular, sent out a press release ensuring customers that its Combivent will be available until December 31, 2013.
BI petitioned FDA for an extension to ensure that it had a replacement treatment available before Combivent was phased out. The company has invested nearly 10 years on this new drug—which is not quite ready, but should be available well before the deadline, according to Emily Baier, public relations manager for BI.
For inhaled devices, FDA views the device and compound as one product, so to create a CFC-free treatment, companies must submit a new drug application.
According to the Montreal Protocol on Substances that Deplete the Ozone Layer, all CFC products must be eliminated to protect the ozone layer. Baier told Pharm Exec that inhalers hardly register on the CFC scale, but the treatments must be phased out due to the regulations. “Combivent inhalers use approximately 150 tons of CFCs per year,” Baier said. “By comparison, when CFC production was frozen in 1986, global CFC production was over 1.1 million metric tons per year.”
The seven CFC inhalers scheduled for phase out are:
• Tilade Inhaler (nedocromil), made by King Pharmaceuticals; last date for sale: June 14, 2010
• Alupent Inhalation Aerosol (metaproterenol), made by Boehringer Ingelheim Pharmaceuticals; last date for sale: June 14, 2010
• Azmacort Inhalation Aerosol (triamcinolone), made by Abbott Laboratories; last date for sale: December 31, 2010
• Intal Inhaler (cromolyn), made by King Pharmaceuticals; last date for sale: December 31, 2010
• Aerobid Inhaler System (flunisolide), made by Forest Laboratories; last date for sale: June 30, 2011
• Combivent Inhalation Aerosol (albuterol and ipratropium in combination), made by Boehringer Ingelheim Pharmaceuticals; last date for sale: December 31, 2013
• Maxair Autohaler (pirbuterol), made by Graceway Pharmaceuticals; last date for sale: December 31, 2013