Food and Drug Administration
The committee will discuss the continued need for thedesignation of OTC epinephrine-metered dose inhalers
for the Treatment of asthma as an essential use of ozone-depleting substances (ODSs) under
Sec. 2.125 (21 CFR 2.125).
Wyeth Consumer Healthcare
The statements contained in this document(s) are those
of the product's sponsor, not FDA, and FDA does not
necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or
effectiveness of the product described in this document.
Portions of this document have
been determined to be exempt from disclosure under the Freedom of Information
(the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.