Theophylline cough/cold products barred from sale after January 1996 -- FDA final rule.
This article was originally published in The Tan Sheet
Executive Summary
THEOPHYLLINE-CONTAINING OTC COUGH/COLD PRODUCTS BARRED FROM SALE after Jan. 29, 1996 under a final rule issued by FDA on July 27. The rule establishes that OTC cough/cold combination drug products containing theophylline are Category II (not safe and effective) and misbranded. "Therefore," the agency stated, "on or after Jan. 29, 1996, no OTC cough/cold combination drug products containing theophylline may be initially introduced or initially delivered into interstate commerce unless they are the subject of an approved application."
You may also be interested in...
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
People In Brief
Perrigo promotes in pricing, planning