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Executive Summary

FDA CONSIDERS ANDA SUBMISSIONS INELIGIBLE FOR LABELING EXCLUSIVITY under the Waxman/Hatch law provisions, FDA Div. of Generic Drugs Deputy Director Kent Johnson told a Regulatory Affairs Professionals Society workshop Aug. 7. Asked whether only NDA holders could seek exclusivity, Johnson replied: "It is my understanding that exclusivity can only be granted if the appIication was approved under ec. (b) [which applies to NDAs] and not under sec. (j) (which refers to ANDAs[. Johnson noted that the new patent/ANDA law "specifically points out, in the two year exclusivity that came about during the window period, that ANDAs could not be eligible for exclusivity and this is the reading of the agency." In addition, Johnson asserted in his prepared remarks: "There is no way an ANDA product can break exclusivity, even by conducting similar clinical studies to support the proposal. By contrast, a full NDA or "paper" NDA product can conduct the required studies to obtain use of the new claim." In a reIated case, Zenith is currently seeking marketing exclusivity from other generic tolazamide products via a civil complaint filed against FDA based on rat teratology studies conducted by the firm. However, Zenith's tolazamide approval was based on a "paper" NDA submission. The firm chose not to convert the submission into a ANDA under the new law.

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