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Fison’s Proferdex

Executive Summary

FDA approval of Fison's NDA for the iron dextran injectable product is "reinstated," a Nov. 23 Federal Register notice says. Fisons had requested the withdrawal of the NDA (17-807) in July 1991. In an April 15 letter, however, the firm told FDA that the Proferdex NDA and product "constitute viable and valuable corporate assets, and Fisons intends to explore the supply, either directly or indirectly, of Proferdex product to the market." Fisons attested that the company was in "good faith negotiations" with Lotus Biochemical Corp. of Bland, Va., and other firms to "provide rights" to Proferdex to third parties. Fisons' iron dextran injection sold under the tradename Imferon, for which the company holds a separate NDA, has been unavailable in the U.S. since May 1991 due to manufacturing compliance problems at the firm's U.K. facility.

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