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Executive Summary

GENERIC DIAZEPAM APPROVALS WILL GET HHS PUBLICITY BOOST through a press conference scheduled by the dept. for Sept. 2 HHS notified news organizations that the press conference would be held to discuss a "big generic drug approval," presumably the first set of ANDA clearances for generic versions of Roche's Valium. The press conference will be conducted by HHS Secty. Heckler. Although it has previously issued press releases upon the approval of initial generic versions of major post-1962 drugs, HHS has not set up a full press briefing to announce such an approval. However, the high consumer recognition of the Valium tradename gives it symbolic value which is unusual for an Rx product. The approval of generic versions of such a highly visible branded drug gives the administration an opportunity to highlight the action in terms of cost savings for consumers. Roche may also be considering a lawsuit to forestall generic marketing of diazepam. The firm still has a petition pending at FDA to require that generic mfrs. of diazepam perform further studies before they are approved for marketing.

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