OTC Labeling Final Rule Extension For ANDA Holders Requested By Perrigo
This article was originally published in The Tan Sheet
Executive Summary
FDA's draft guidance stating ANDA holders need not wait for OTC reference listed drug makers to implement "Drug Facts" labeling before they use such labeling would create an "unexpected hardship" on private labelers, Perrigo maintains in comments to the agency.
You may also be interested in...
FDA "Drug Facts" Templates Supersede Reference Listed Drug Labeling - FDA
Generic drugs approved under ANDAs may conform to "Drug Facts" labeling as it appears in templates posted on FDA's Web site without having to wait for the reference listed drug's labeling to be approved.
Generic Drug Revised Labeling Mock-Ups Available On FDA Web Site
Private label firms will be able to reference labeling examples for seven OTC drug categories when revising product labeling to conform to the provisions of the OTC labeling final reg, FDA asserts in a draft guidance for industry published in the Feb. 22 Federal Register.
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