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Executive Summary

GENEVA PHARMACEUTICALS HAS FIRST LEGITIMATE AB-RATED GENERIC DYAZIDE following FDA approval of its ANDA for triamterene 50 mg/hydrochlorothiazide 25 mg capsules on July 31. Under a 1990 co- marketing agreement with Geneva, Zenith will also market the triamterene/hydrochlorothiazide product under its own label. Geneva said it is awaiting completion of an FDA process validation inspection before it can launch its generic version of Dyazide. The company anticipates that FDA inspectors will begin the inspection the week of Aug. 5 and will finish before the month is over. The Geneva/Zenith product is not the first generic version of SmithKline Beecham's Dyazide to be approved by FDA. FDA withdrew the approved ANDAs for Bolar's and Vitarine's generic versions of SmithKline Beecham's Dyazide after the agency discovered that the approvals were based on fraudulent ANDA submissions. Rugby Labs currently markets a generic Dyazide that is manufactured by SmithKline Beecham. The generic company acquired rights to market the product through a manufacturing and distribution agreement signed in August 1990 ("The Pink Sheet" Aug. 27, 1990, p. 3). SmithKline set up the marketing deal to lessen the blow of losing its renewed monopoly to inevitable generic competitors. Dyazide has annual sales over $ 200 mil. Geneva said its generic will be competitively priced to the brandname drug and to Rugby's product. Rugby sells its product at a 25% discount to Dyazide. To support the launch, Geneva said it plans to run ads for the antihypertensive in major medical journals. The ads are currently being reviewed by Geneva and will be sent to FDA for pre- clearance. Promotions will stress the product's AB-rating (therapeutically equivalent) to Dyazide and that it is the only "true" generic available, Geneva said. The delay in the launch is the latest in a series of delays for Geneva in moving the ANDA through the post-generic scandal FDA. Almost a year ago, FDA conducted a pre-approval inspection for Geneva's generic version of Dyazide. The approval comes two years and four months after the ANDA was filed with FDA in March 1989. Geneva said that along with the usual battery of biostudies, FDA required the firm to conduct additional testing as a result of the agency's experience with Bolar's and Vitarine's fraudulent bioequivalence studies and due to the poor bioavailability of SmithKline's formulation of Dyazide. Geneva Pharmaceuticals is a wholly-owned subsidiary and generic drug arm of Ciba-Geigy. In January 1991, Cord Labs, the manufacturing branch, and Geneva Generics, the distribution branch, were combined and renamed Geneva Pharmaceuticals.

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