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CARTER-WALLACE’s NDA FOR BUTIBEL SEDATIVE IS UNDER REVIEW BY FDA

Executive Summary

CARTER-WALLACE's NDA FOR BUTIBEL SEDATIVE IS UNDER REVIEW BY FDA, which apparently is considering withdrawing the antispasmodic sedative's approval in connection with its DESI product status. "The company is awaiting a reply from the FDA concerning its request for hearing on Butibel," Carter-Wallace says in its recently-released 1992 annual report. The company markets the combination product (belladonna extract and butabarbital sodium) in elixir and tablet forms. FDA already has proposed withdrawing Carter-Wallace's NDA for the combination tranquilizer product Deprol (meprobamate and benactyzine) under DESI. An Administrative Law Judge ruled that the Deprol NDA should be withdrawn, Carter-Wallace said; the company has appealed the decision to FDA Commissioner Kessler. Both Butibel and Deprol remain on the market, a spokesperson said. FDA's Pulmonary-Allergy Drugs Advisory Committee recommended in March that Carter-Wallace's mucolytic expectorant Organidin (iodinated glycerol) should remain on the market pending FDA review of efficacy data to determine benefit versus potential carcinogenicity ("The Pink Sheet" March 30, p. 5). Carter-Wallace "is developing additional data in support of the safety and efficacy of the [Organidin] products and has implemented" the committee's other recommendations, the annual report states. "Withdrawal of the DESI products subject to review would not require material write-offs and would not have a material adverse effect on sales or earnings," the annual report says. "Any substantial reduction in Organidin sales or the discontinuance of marketing of the Organidin products as a result of regulatory action would not require material write-offs and would not have a material adverse effect on the Company's financial position, but in the absence of related reductions in marketing and other operating expenses, would have a material adverse effect on earnings," the report notes.
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