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Executive Summary

BUTALBITAL-ANALGESIC COMBOS LACKING FDA APPROVAL MUST BE WITHDRAWN from the market, FDA told companies which, according to a recent FDA drug listing printout, manufacture and/or market combos without the required supplemental or ANDA approval. As part of the DESI class action against the unapproved combos, the agency issued approximately 50 regulatory letters and asked district offices to forward information on "any additional drug products for human use, containing a barbiturate-analgesic combination . . . so that we may institute prompt follow-up where indicated." The class action was taken by the agency following a Federal Register DESI notice in February that mfrs. of the butalbital-analgesic drug products "who do not hold either an approved [ANDA] or supplemental [NDA] by Aug. 10, 1984 will be subject to regulatory action." Included among the 50 firms receiving a reg letter were Sandoz (Fiorinal w/codeine Nos. 1, 2 and 3), Generix (Fiorgen tabs, caps, and No. 3 caps w/codeine), and O'Neal, Jones & Feldman (Bancap with codeine). FDA told the mfrs. that "if significant stocks of this drug remain in trade channels, we will require that they be recalled from the direct consignee and at the whsle. level." The agency said firms no longer marketing the product "must delist it from the Drug Listing files" in accordance with federal regulations.

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