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McNeil's Haldol

Executive Summary

FDA again rejects the company's request for five-year exclusivity for Haldol (haloperidol decanoate). McNeil submitted a citizen's petition in October 1987 requesting that the agency reconsider its determination that exclusivity for the product would be three years. On Jan. 12, 1989, two days before exclusivity was to run out on Haldol, McNeil submitted another petition to stay the approval of any haloperidol decanoate ANDAs. FDA said in a July 26 letter to the company that the "five-year provision does not apply to haloperidol decanoate because it is not a new chemical entity by an ester of the previously approved ingredient haloperidol." By the same reasoning, the agency also denied a stay of ANDA approvals for the product.
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PS016079

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