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Mead Johnson Desyrel exclusivity

Executive Summary

Firm resubmits exclusivity request and could be preparing for court challenge if FDA denies again. Mead Johnson maintains that Desyrel final approval did not come until mid-January or early February 1982, qualifying the product for 10 years of exclusivity protection under the Waxman/Hatch Act. FDA maintains the product was approved on Dec. 24, 1981 which negates the exclusivity claim ("The Pink Sheet" Sept. 2, T&G-1).

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