Glaxo Zantac 75 OTC switch to launch in early 1996 following Dec. 19 approval; Axid OTC is "approvable".
GLAXO OTC ZANTAC 75 "#1 PRESCRIBED" CLAIM MUST BE EXCLUDED FROM INSERT, FDA said in its Dec. 19 approval letter to Glaxo Wellcome for the over-the-counter version of ranitidine. The agency directed Glaxo to "delete the statement `Since 1988, the medicine in Zantac 75 has been the #1 prescribed acid reducer'" from the package insert. The Rx-to-OTC switch product will be marketed by Warner-Lambert under a joint venture arrangement with Glaxo Wellcome.