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Executive Summary

ETHOHEPTAZINE-CONTAINING ANALGESIC PRODUCT MARKET RECALL is being required by FDA as a follow-up to a withdrawal of NDA approval last spring under the DESI program. FDA noted in a reg letter issued to all remaining known marketers of the products that "significant stocks of the drug product(s)" remaining in trade channels should be recalled. The agency added that firms which have discontinued marketing the drugs should notify FDA so that the products can be dropped from FDA's drug listing files. FDA is implementing the class action following withdrawal under the DESI review of all NDAs for the ethoheptazine products, as announced in an April 30 Federal Register notice. The notice's effective date was May 30. The final order withdrawing the NDAs, in turn, followed the agency's proposal for withdrawal issued in 1978. FDA noted in the reg letter that only Wyeth Labs requested a hearing on the proposal, but that the company subsequently withdrew the request and discontinued marketing the products. A group of 15 firms identified by FDA as having marketed ethoheptazine analgesic products received the letter.Among them were Henry Schein, Geneva, Zenith and Lemmon. FDA asked the firms receiving the reg letter to respond within 10 days stating the actions that will be taken to discontinue marketing the drug. FDA asked that the reply include: "an estimate of the quantity of the drug(s) manufactured or received within the past 12 months; an estimate of the size and frequency of shipments made by you in the past 12 months; an estimate of the amount of the drug(s) that is in inventory under your control and of the amounts that remain in channels of distribution outside of your control; the date of discontinuance in the event that you have already discontinued marketing this drug product(s); your intention with respect to the disposition of your inventories and the withdrawal of outstanding stocks from the market."

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