!

 

(c)    Notwithstanding an answer of “yes” to (a) or (b), are there other reasons to believe that the applicant should not be credited with having “conducted or sponsored’ the study?  (Purchase studies may not be used as the basis for exclusivity.  However, if all rights to the drug are purchased (not just studies on the drug), the applicant may be considered to have sponsored or conducted the studies sponsored or conducted by its predecessor in interest.)

                                                                        YES /___/        NO /___/

 

      If yes, explain: ____________________________________________________________

     

      ________________________________________________________________________

 

      ________________________________________________________________________

 

Signature of Preparer                                                                            Date

Title:

 

Signature of Office or Division Director                                                  Date

 

 

 

cc:

Archival NDA

HFD-      /Division File

HFD-      /RPM

HFD-610/Mary Ann Holovac

HFD-104/PEDS/T.Crescenzi

 

 

form OGD-0011347

Revised 8/7/95; edited 8/8/95; revised 8/25/98, edited 3/6/00

 

 

Page 9

 

 

 

Back a Page
Next Page
Back to Wellbutrin XL NDA Index Page
Back to Main Index Page