GENERIC CIMETIDINE WINS US APPROVAL

Mylan Laboratories has received approval from the US Food and Drug Administration for a generic version of SmithKline Beecham's antiulcerant drug Tagamet (cimetidine), in 200mg, 300mg, 400mg and 800mg strengths. The company is now in a position to start shipping the product as soon as the US patent for cimetidine runs out, on May 17, 1994.

Mylan becomes the first generics house to gain approval for what promises to be a high-earning sector of the generics market, particularly if the cheaper drug can entice prescribers away from the world's biggest-selling drug, Glaxo's Zantac (ranitidine). Many insurance companies consider ranitidine and cimetidine to be clinically equivalent.

Mylan now has a few months to carry out premarketing work in preparation for the launch of the product, and will hope to gain a marketing edge over other generic cimetidine developers. According to the Wall Street Journal, David Saks, an analyst with Gruntal & Co, thinks that generic cimetidine sales could boost Mylan's earnings by between 15 and 30 cents by fiscal 1995.