Conclusions and Recommendations:

From the perspective of Clinical Pharmacology and Biopharmaceutics, dada as provided by the DSI have been used to re-evaluate bioequivalence for bupropion XL and Wellbutrin (IR) for the erythrohydrobupropion metabolite.  The results still demonstrate bioequivalence on the 90% confidence intervals of the ratio of the geometric means of the pertinent PK parameters for Wellbutrin XL compared to Wellbutrin (IR) at steady state.

 

                                                              Sally Usdin Yasuda, MS, PharmD

                                                              Reviewer, Neuropharmacological Drug Section, DPE I

                                                              Office of Clinical Pharmacology and Biopharmaceutics

 

 

 

Concurrence:   Ramana Uppoor, PhD

                     Team Leader, Neuropharmacological Drug Section, DPE I

                     Office of Clinical Pharmacology and Biopharmaceutics

 

cc:       HFD-120    NDA 21515

                          CSO/D. Bates

                          /Biopharm/S. Yasuda

                          /TL Biopharm/R. Uppoor

          HFD-860    /DD DPE1/M. Mehta/C. Sahajwalla

 

                         

 

 

 

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