NDA 20-358

Page 2

 

 

from new patients or additional visits from ongoing patients, is small relative to what we already have, the safety update can focus on identifying any important new adverse events not previously reported.  It may be sufficient to provide a line listing of any patients meeting the following criteria and not previously reported:  deaths; patients dropping out for adverse events; and patients experiencing serious adverse events.  Narrative summaries should be provided for all such patients.  In selected cases, we may ask for copies of case report forms.  The Division will be happy to discuss with you more specifically what will be needed in the safety update.

 

 

Regulatory Status Update

 

Please provide any new information on the regulatory status of Wellbutrin* SR worldwide.  We require a review of the status of all actions with regard to this drug, either taken or pending before a foreign regulatory authorities.  Approval actions can be noted, but we ask that you describe in  detail any and all actions taken that have been negative, supplying a full explanation of the views of all parties and the resolution of the matter.  In addition, we ask that you provide us any current foreign labeling for Wellbutrin* SR, if appropriate, along with English translations when needed.

 

MANUFACTURING AND CONTROLS

 

1.        Expiration Date

 

Please note that, at this time, we are only approving an 18-month expiry date for the drug product.

 

 

2.        Container Labels

 

The storage statement on the carton and in the package insert should be revised to conform to the FDA uniform storage statement.  For a drug product demonstrated to be stable at 25˚C/60%RH or 30˚C/60%RH and intended to be stored at controlled room temperature, the recommended wording is: “Store at controlled Room Temperature 20˚-25˚C (68˚-77˚F)  [See USP]”.  Additionally, all container labeling must be revised to state “Dispense in a tight, light resistant container”.

 

BIOPHARMACEUTICS

 

Dissolution Specification

 

The Division of Biopharmaceutics ask that you agree to the following dissolution method and specification for all strengths of Wellbutrin* SR tablets (50, 100, and 150 mg):

 

 

 

 

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