NDA 20-358

Page 2

 

Biopharmaceutics

 

As agreed upon in our conference call dated September 12, 1996, the Agency is approving the following dissolution method and specifications for all strengths of Wellbutrin* SR tablets (50,100, and 150 mg):

 

 

^aMethod:

 

Manufacturing and Controls

 

Expiration Date

 

As agreed upon in our conference call dated September 12, 1996, the Agency is approving an 18-month expiry date for the drug product.

 

Please submit sixteen copies of the FPL as soon as it is available, in no case more than 30 days after it is printed.  Please individually mount ten of the copies on heavy weight paper or similar material.  For administrative purposes this submission should be designated “FINAL PRINTED LABELING” for approved NDA 20-358.  Approval of this labeling by FDA is not required before its use.

 

As requested in our approvable letter dated March 12, 1996, please submit three copies of the introductory promotional material that you propose to use for this product.  All proposed materials should be submitted in draft or mock-up form, not final print.  Please submit one copy to this Division and two copies of both the promotional material and the package insert directly to:

 

Food and Drug Administration

Division of Drug Marketing, Advertising and Communications, HFD-40

5600 Fishers Lane

Rockville, Maryland  20857

 

Should additional information relating to the safety and effectiveness of the drug become available, revision of that labeling may be required.

 

We remind you that you must comply with the requirements for an approved NDA set forth under 21 CFR 314.80 and 314.81.

 

 

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