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.

According to FDA, the "number one" statement is excessively promotional and unnecessary in the package insert. As presented, the statement does not provide any information specifically helpful to the consumer, the agency said. According to IMS America data cited by the company, 27.3 mil. prescriptions were written for Zantac in 1994, compared to 7.8 mil. for Pepcid and 6.6 mil. for Tagamet.

Warner-Lambert is banking on the Zantac prescription leadership position to propel the product into the competitive over-the-counter H2 antagonist market, the company said in announcing FDA's Dec. 19 approval of ranitidine for the treatment of heartburn.

The third H2 antagonist to receive OTC approval, the ranitidine 75 mg product faces the challenge of catching up to the competition, J&J-Merck's Pepcid AC (famotidine 10 mg) and SmithKline Beecham's Tagamet HB (cimetidine 100 mg), which were launched over the summer. A fourth competitor, Lilly/American Home Product's Axid (nizatidine), has reached the "approvable" stage at FDA.

Zantac 75 is slated to launch in the first quarter. A "high-profile" advertising campaign, which will "focus on the product's heritage" as well as its "clinical benefits in relieving heartburn," will involve national television, radio and print media, the company said. Promotional vehicles such as coupons and store displays also will be used. According to Warner-Lambert, the marketing budget for Zantac 75 will be comparable to the amounts spent for Pepcid AC and Tagamet HB.

The OTC product will retain the distinctive five-sided shape of the 150 mg tablet of prescription Zantac. Glaxo has been running direct-to-consumer ads for the prescription product that include pictures of Zantac 150 and the tag line "only Zantac is Zantac."

Merck employed a different strategy with Pepcid AC: the OTC product is a pink rounded square tablet where the prescription is a beige, film-coated U-shaped tablet. Zantac 75 will be differentiated from the higher-dose prescription product by color (pink versus peach) and embossing ("Z" versus "Zantac 150").

Zantac 75 initially will be available in 4-, 10- and 20-tablet packages. The recommended dose for adults and children ages 12 and older will be one tablet, not to exceed two doses in 24 hours. The face of the 10-tablet outer carton will be white with fading shades of blue in the upper-left corner. An image of the five-sided tablet and the name -- Zantac 75 -- will be displayed in upper-case letters in the center of the panel.

FDA's approval of Zantac 75 comes approximately five months after the agency's Arthritis and Nonprescription Drugs Advisory Committees recommended Rx-to-OTC switch approval for the H2 antagonist ("The Pink Sheet" July 17, 1995, p. 8).