administrative and correspondence …...environmental sciences, pharmacokinetics, dynamics and...

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER: 22-488

ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS

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Lyrica Oral Solution~Module 1, Section 1.6 Environmental Assessment 24NOV2008

Environmental Assessment

Lyrica Oral Solution(ß

NDA#

20 mg/ml Pregabalin, 16 fl. oz. bottle

This application is for a new oral solution formulation for use in the treatment of all currentlyapproved indications. As this new formulation wil replace usage in the current populationwho has diffculty taking capsules, there wil be no increase in environmental exposure.

Claim for Categorical Exclusion According to 21 CFR Part 25.15 (a),(d)

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Pfizer Inc claims a categorical exclusion to the environmental analysis requirements inaccordance with categorical exclusion criteria 21 CFR Part 25.31 (a): Action on a NDA; ifthe action does not increase the use of the active moiety. Pfizer Inc claims that to the best ofour knowledge no extraordinary circumstances exist.enooN

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Preparer:

Jon F. Ericson, Senior Principal Scientist, Pfizer Global Research and Development,Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. AnalyticalChemist with M.S. and 22 years experience in Drug Metabolism and Environmental Science.

The undersigned official states that the information presented is true, accurate, and completeto the best of Pfizer Inc's knowledge.

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ior Prncipal ScientistEnvironmental Sciences! PDMpfzer Global Researh and DevelopmentGrton, cr 06340 USA

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