moieties in the drug product?  If, for example, the combination contains one never-before-approved active moiety and one previously approved active moiety, answer “yes.”  (An active moiety that is marketed under an OTC monograph, but that was never approved under an NDA, is considered not previously approved.)

 

If “yes,” identify the approved drug product(s) containing the active moiety, and, if known, the NDA # (s).

 

NDA  #

 

NDA  #

 

NDA  #

 

IF THE ANSWER TO QUESTION 1 OR 2 UNDER PART II IS “NO,” GO DIRECTLY TO THE SIGNATURE BLOCKS ON Page 8.  IF “YES,” GO TO PART III.

 

 

PART III:  THREE-YEAR EXCLUSIVITY FOR NDA’S AND SUPPLEMENTS

 

To qualify for three years of exclusivity, an application or supplement must contain “reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant.”  This section should be completed only if the answer to PART II, question 1 or 2, was “yes.”

 

1.       Does the application contain reports of clinical investigations?  (The Agency interprets “clinical investigations” to mean investigations conducted on humans other than bioavailability studies.)  If the application contains clinical investigations only by virtue of a right of reference to clinical investigations in another application, answer “yes,” then skip to question 3(a).  If the answer to 3(a) is “yes,” for any investigation referred to in another application, do not complete remainder of summary for that investigation.

 

                                                                                    YES /__/          NO /_X_/

 

IF “NO,” GO DIRECTLY TO THE SIGNATURE BLOCKS ON Page 9.

 

2.       A clinical investigation is “essential to the approval” if the

 

 

Page 4

 

 

 

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