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| |  First CFC-Free Metered Dose Inhaler Approved for Use in the U.S. ST. PAUL, Minn., Aug. 16, 1996-- 3M Pharmaceuticals, a division of 3M (NYSE: MMM), today received approval from the Food and Drug Administration (FDA) to market the first chlorofluorocarbon-free (CFC-free) metered dose inhaler (MDI) in the United States. 3M will manufacture the albuterol sulfate CFC-free MDI and Schering-Plough Corporation (NYSE: SGP), in Madison, NJ, will be the exclusive U.S. distributor. The product will be marketed under the brand name Proventil(R) HFA. 3M's CFC-free MDI is a breakthrough in MDI technology that will enable patients to continue to use their MDIs without contributing to the damage of the ozone layer caused by chlorofluorocarbons (CFCs). The CFC-free technology uses hydrofluoroalkane-134a (HFA-134a) as a propellant for the asthma medication. HFA-134a has been approved by the Environmental Protection Agency (EPA) as a replacement substance for CFCs. "We're very excited about this new product. 3M has found a way to balance the patients' needs with international environmental guidelines -- and there's no compromise to the product," said Fran DuMelle, deputy managing director, American Lung Association. "We look forward to the day when all patients who rely on MDIs will use a CFC-free inhaler." "3M's search for an alternative propellant to CFCs used in MDIs began as a response to the 1987 Montreal Protocol which set a world-wide goal to end CFC usage by January 1, 1996," said George Meredith, executive vice president, Life Sciences Sector and Corporate Services. "For the past seven years, we have placed the highest priority on developing a CFC-free MDI. We are proud to be bringing the world's only CFC-free metered dose inhaler to the U.S. market." The Montreal Protocol was sponsored by the United Nations Environment Programme (UNEP) and signed by more than 150 countries. Because 11 million patients in the United States rely on medicines delivered by MDIs as a cornerstone for treatment of their asthma and other respiratory diseases, an exemption was granted for those inhalers currently on the market to enable rigorous safety and efficacy testing procedures for the new CFC-free technology to be completed. Few patients are aware that their pocket-sized delivery system contains CFCs, which contribute to the depletion of the ozone layer. Recent recommendations made by the Technology and Economic Assessment Panel (TEAP) of UNEP request the phase-out of CFC products when medically acceptable CFC-free alternatives are available and call for a "major reduction" in the use of CFC-containing MDIs by the year 2000, with a proposed complete ban by the year 2005. The panel expects specific proposals for the phase-out of CFC MDIs to be in place by 1997, but recommends that signatories to the Protocol act now to limit their availability. "Today's FDA approval of the first CFC-free MDI is a welcome step in protecting the ozone layer," said Mary Nichols, EPA's Assistant Administrator for Air and Radiation. "It is our hope that similar industrial innovation will ultimately make possible the replacement of all CFCs in pharmaceutical products, and we eagerly await the next round of technology innovations that will drive the CFC phase-out to a conclusion." 3M Pharmaceuticals is committed to the continued development of this technology that will allow the phase-out of other CFC-containing MDIs currently on the market. 3M Pharmaceuticals is currently working with seven different companies on formulating eleven different drugs. 3M Pharmaceuticals is renowned for its technological expertise in the field of respiratory medicine, particularly in the development of metered dose inhalers which are widely used in the treatment of asthma. 3M pioneered the development of the first portable MDI in the 1950s, and today more than half of all inhalers produced globally utilize 3M technology. Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and health care products worldwide.
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