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SMITHKLINE ATTACKS GENERIC SUBSTITUTION FOR DYAZIDE

Executive Summary

SMITHKLINE ATTACKS GENERIC SUBSTITUTION FOR DYAZIDE in an Aug. 3 letter to pharmacists and physicians. "Uncertainty" regarding the validity of generic Dyazide approvals "certainly reaffirms the necessity for dispensing your Dyazide prescriptions with the branded product," the firm wrote to pharmacists. "As you know," the letter explains, Vitarine "admitted falsifying the data on which their product was approved, and therefore" the generic firm "ceased manufacturing" the antihypertensive and recalled it "from your stores (as well as from wholesalers)." Furthermore, SmithKline continued, information "released today by the congressional committee investigating the generic drug approval process calls into question the product approval of the only remaining generic manufacturer," Bolar. The House Commerce/Oversight Subcommittee informed FDA on Aug. 1 that June memoranda from Bolar's contract laboratory, PharmaKinetics, questioned the color of the test sample contents of Bolar's product vis a vis SmithKline's. The memos indicated that the test product sample was "darker yellow" than other Bolar samples, though not as dark as Dyazide. FDA is currently analyzing all test product and reference product samples from the Bolar studies. The generic company insists it did not attempt to disguise Dyazide as its own product in the tests. In his letter to FDA, subcommittee Chairman Dingell (D-Mich.) said only that Bolar "may well have" attempted a switch. He was reportedly angered that the firm did not report PharmaKinetics' questions about the sample colors to FDA and the subcommittee. On the other hand, the test samples were submitted to the agency. SmithKline's letter to pharmacists and physicians, signed by Smith Kline & French President Frederick Kyle, points out that "Dyazide remains unchanged. It is the same drug tested, approved and marketed by SK&F 25 years ago. We have made no changes in Dyazide formulation."
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