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Mallinckrodt levorphanol DEA application

Executive Summary

An Administrative Law Judge has recommended that Mallinckrodt's application for egistration as a bulk mfr. of the Schedule II controlled substance be approved. Roche, the only firm registered by DEA as a levorphanol bulk mfr., objected to Mallinckrodt's application on grounds firm did not have a commercial outlet. The Drug Enforcement Agency explained in an April 29 Federal Register notice that Roxane would like to produce a levorphanol dosage form and asked Mallinckrodt to be a supplier of the bulk product after Roche refused to sell to Roxane.

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