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Gabapentin ANDA Comparing Tabs To Caps Is Not Complete, Petition Says

Executive Summary

An ANDA for gabapentin tablets that references Warner-Lambert's Neurontin capsules should be treated by the agency as "not substantially complete," an Aug. 12 citizen's petition to FDA argues.

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Pfizer Neurontin petition denied

Pfizer citizen petition claiming that gabapentin tablet ANDAs are incomplete if they use Neurontin capsules as reference product is denied by FDA. The agency is not required "to make a determination about bioequivalence or about the approvability or likely approvability of an ANDA prior to accepting the ANDA for review," a Jan. 18 letter says. Such a "substantive" review is only necessary for approval, FDA said. Pfizer filed the citizen petition on the anti-epileptic drug Aug. 12, 1999 (1"The Pink Sheet" Aug. 30, 1999, p. 23)...

Pfizer Neurontin petition denied

Pfizer citizen petition claiming that gabapentin tablet ANDAs are incomplete if they use Neurontin capsules as reference product is denied by FDA. The agency is not required "to make a determination about bioequivalence or about the approvability or likely approvability of an ANDA prior to accepting the ANDA for review," a Jan. 18 letter says. Such a "substantive" review is only necessary for approval, FDA said. Pfizer filed the citizen petition on the anti-epileptic drug Aug. 12, 1999 (1"The Pink Sheet" Aug. 30, 1999, p. 23)...

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