EXCLUSIVITY SUMMARY for NDA # __21-515____  SUPPL #

 

Trade Name  Wellbutrin XL

 

Generic Name  bupropion hydrochloride extended release tablets

 

Applicant Name  GlaxoSmithKline__________   HFD-120

 

Approval Date  August 28, 2003

 

PART I:  IS AN EXCLUSIVITY DETERMINATION NEEDED?

 

1.       An exclusivity determination will be made for all original applications, but only for certain supplements.  Complete Parts II and III of this Exclusivity Summary only if you answer “YES” to one or more of the following questions about the submission.

 

a)      Is it an original NDA                                         YES /_X_/        NO /___/

 

b)      Is it an effectiveness supplement?                      YES /___/        NO /_X_/

 

      If yes, what type (SE1, SE2, etc.)?

 

c)      Did it require the review of clinical data other than to support a safety claim of change in labeling related to safety:  (If it required review only of bioavailability or bioequivalence data, answer “NO.”)

 

If your answer is “no” because you believe the study is a bioavailability study and, therefore, not eligible for exclusivity, EXPLAIN why it is a bioavailability study, including your reasons for disagreeing with any arguments made by the applicant that the study was not simply a bioavailability study.

The pivotal study (AK1BioVail2543) on which this approval was based was a bioequivalence (comparative bioavailability) study which evaluated the bioavailability of a once-daily bupropion (HCL) extended-release tablet test formulation relative to reference Wellbutrin tablets under steady-state, fasting conditions.

 

 

 

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