CFC-Containing MDIs Are "Essential" Until Multiple Alternatives Available
This article was originally published in The Tan Sheet
Executive Summary
More than one CFC-free product alternative must be available before FDA phases out a CFC-containing metered dose inhaler that is available under multiple NDAs or in multiple strengths, the agency suggests in a proposed rule on ozone depleting substances (ODS) published in the Sept. 1 Federal Register.
You may also be interested in...
Epinephrine bronchodilators retain FDA essential-use designation allowing CFCs -- ANPR.
EPINEPHRINE BRONCHODILATOR PRODUCTS RETAIN ESSENTIAL-USE DESIGNATION because epinephrine is the "only active moiety" used in OTC drug products containing chlorofluorocarbon propellants, FDA observes in a March 6 advance notice of proposed rulemaking on CFCs in self-pressurized container whose uses are no longer essential. "These OTC drug products are available to patients who may not have access to prescription drugs. Therefore," the ANPR states, "FDA has tentatively determined that prescription drugs should not be considered as alternatives to drug products containing epinephrine."
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands