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."