Wellbutrin XL NDA 21-515

investigations, identify each such investigation and the NDA in which each was relied upon:

NDA # __________________ Study #

(b) For each investigation identified as “essential to the approval,” does the investigation duplicate the results of another investigation that was relied on by the agency to support the effectiveness of a previously approved drug product.

Investigation #1 YES /___/ NO /___/

Investigation #2 YES /___/ NO /___/

Investigation #3 YES /___/ NO /___/

If you have answered “yes” for one or more investigations, identify the NDA in which a similar investigation was relied on:

NDA # __________________ Study #

(c) If the answers to 3(a) and 3(b) are no, identify each “new” investigation in the application or supplement that is essential to the approval (i.e., the investigations listed in #2(c), less any that are not “new”):

Investigation #1 YES /___/ NO /___/

Investigation #2 YES /___/ NO /___/

Investigation #3 YES /___/ NO /___/

To be eligible for exclusivity, a new investigation that is essential to approval must also have been conducted or sponsored by the applicant. An investigation was “conducted or sponsored by” the applicant if, before or during the conduct of the investigation, 1) the applicant was the sponsor of the IND named in the form FDA 1571 filed with the Agency, or 2) the applicant (or its predecessor in interest) provided substantial support for the study. Ordinarily, substantial

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