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Neurontin generics “approvable”

Executive Summary

Ivax, Eon and Purepac ANDAs for generic versions of Pfizer's Neurontin (gabapentin) are "approvable" at FDA pending resolution of language in labeling referring prescribers to Pfizer's label for protected pediatric information. After labeling issues are resolved, the ANDAs will be tentatively approved until the 30-month stay of approval related to Pfizer's "lactam-free" bulk gabapentin expires in December (1"The Pink Sheet" Dec. 24, 2001, p. 18)...
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