NDA 20-358

Page 8

 

Within 10 days after the date of this letter, you are required to amend the application, or notify us of your intent to file an amendment, or follow one of the other alternatives under 21 CFR 314.120.  In the absence of such action FDA may proceed to withdraw the application.  Any amendment should respond to all the deficiencies listed.  We will not process a partial reply as a major amendment nor will the review clock be reactivated until all deficiencies have been addressed.

 

Under section 736(a)(1)(B)(ii) of the Prescription Drug User Fee Act of 1992, this letter triggers the remaining 50% of the fee assessed for this application.  You will receive an invoice for the amount due within the next month.  Payment will be due within 30 days of the date of this invoice.

 

                                                                                                                Sincerely yours,

 

                                                                                                                (no signature)

 

                                                                                                                Robert Temple, M.D.

                                                                                                                Director

                                                                                                                Office of Drug Evaluation I

                                                                                                                Center for Drug Evaluation and Research

 

Enclosures

 

 

 

 

 

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