IF THE ANSWER TO QUESTION 3 IS “YES,” GO DIRECTLY TO THE SIGNATURE BLOCKS ON Page 9 (even if a study was required for the upgrade).

 

 

 

PART II:  FIVE-YEAR EXCLUSIVITY FOR NEW CHEMICAL ENTITIES

(Answer either #1 or #2, as appropriate)

 

1.       Single active ingredient product.

 

Has FDA previously approved under section 505 of the Act any drug product containing the same active moiety as the drug under consideration?  Answer “yes” if the active moiety (including other esterified forms, salts, complexes, chelates or clathrates) has been previously approved, but this particular form of the active moiety, e.g., this particular ester or salt (including salts with hydrogen or coordination bonding) or other non-covalent derivative (such as a complex, chelate, or clathrate) has not been approved.  Answer “no” if the compound requires metabolic conversion (other than deesterification of an esterified form of the drug) to produce an already approved active moiety.

                                                                                    YES /_X_/        NO /___/

 

If “yes,” identify the approved drug product(s) containing the active moiety, and, if known, the NDA #9S).

 

NDA  #  18-644                                    Wellbutrin Immediate Release

 

NDA  #  20-358                                    Wellbutrin Sustained Release

 

NDA  #  20-711                                    Zyban Sustained Release

 

 

2.       Combination product.  N/A

 

If the product contains more than one active moiety (as defined in Part II, #1), has FDA previously approved an application under section 505 containing any one of the active

 

Page 3

 

 

 

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