GLAXO WILL STOP PROMOTION OF RECONSTITUTED FORTAZ IN TRAVENOL's

Executive Summary

GLAXO WILL STOP PROMOTION OF RECONSTITUTED FORTAZ IN TRAVENOL's Viaflex bags in response to a recent reg letter from FDA. Glaxo counsel Hyman, Phelps & McNamara told FDA in a May 11 letter that the firm "will not disseminate materials promoting [the reconstituted] formulation until and unless its status has been clarified and accepted by appropriate agency personnel." FDA notified Glaxo on April 10 that it considers the reconstituted Fortaz (ceftazidime) product to be a new drug because the reconstituted form is not the subject of an approved NDA. The firm's response maintains that "the Fortaz reconstituted by Travenol is expressly in conformance with the approved labeling for Fortaz and, therefore, . . . not an unapproved or uncertified antibiotic drug." Nevertheless, the letter adds, "in a spirit of cooperation with the agency (without necessarily agreeing with the agency's stated position here), Glaxo will voluntarily discontinue any labeling or advertising that promotes the product as reconstituted by Travenol." Fortaz is one of almost 20 reconstituted antibiotics and chemotherapeutics distributed by Travenol, which FDA says need approved NDAs. Travenol has been in discussion with FDA since June 1985 over the status of the reconstituted products. FDA has maintained that reconstituted formulations require regulatory submissions despite approved labeled directions for hospital pharmacy reformulation. Glaxo is reportedly the only company to have received a reg letter for Travenol's reconstituted products. The firm was apparently singled out because it was advertising the availability of Travenol's reconstituted Fortaz. Travenol said it is still marketing reconstituted Fortaz and that discussions with FDA regarding all the reconstituted products are continuing.