On May 30, 2008, the U.S. Food and Drug Administration (FDA) issued a public health advisory to alert patients, caregivers and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled albuterol inhalers will not be available for sale in the U.S. after December 31, 2008.

Please note that this FDA public health advisory relates to prescription albuterol inhalers, and NOT over-the-counter epinephrine inhalers like Primatene^® Mist.

Primatene^® Mist will continue to be available in retail stores through December 31, 2010, in accordance with the Proposed Rule issued by FDA on September 20, 2007 (72FR53711).

For more information on the recent FDA public health advisory: http://www.fda.gov/cder/mdi/albuterol.htm

For more information on the proposed rule affecting CFC-propelled epinephrine inhalers like Primatene^® Mist: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01706.html

The Food and Drug Administration (FDA) announced on September 20, 2007 a proposed change to its regulations that would eliminate the sale of over-the-counter (OTC) epinephrine metered dose (MDIs), like Primatene® , that use chlorofluorocarbons (CFCs) as a propellant by December 31, 2010, due to environmental concerns associated with CFCs.

The public is able to submit comments to the FDA for 60 days, after which the FDA will evaluate the comments and make a final decision that will set a deadline by which OTC MDIs containing CFCs must be off store shelves and may no longer be sold. According to the agency’s recent announcement, it is considering a period of 3 years for product phase out by December 31, 2010.

Wyeth Consumer Healthcare will be required to comply with the FDA’s final decision. However, it’s important to keep in mind that this announcement has no immediate effect on our ability to sell Primatene® . We can continue to make and sell Primatene® , in accordance with the timeline for product phase out that will be announced by the FDA, when it makes its final decision.

The FDA’s recent action is being prompted by an overall effort to eliminate the use of CFCs in all products, due to environmental concerns. CFCs are ozone-depleting substances and there is a global effort underway to eliminate CFCs by a target date of 2010.

Asthma is a serious medical condition, and Wyeth Consumer Healthcare wants to help consumers by educating them about the available resources to identify other treatment options to effectively manage their asthma. After the agency makes its final decision, consumers will be able to access this information here, on our Web site, or by calling our toll free line, 1-8-PRIMATENE.

For more specific information regarding the FDA’s proposed rule or the public comment process visit the Federal Register section of the FDA’s Web site http://www.fda.gov.