NDA 21-515                                         Approval Letter                                                 2

 

 

 

·         A healthcare professional may be unaware that a new formulation of Wellbutrin is available and may therefore assume that a prescription for Wellbutrin XL is actually a prescription for Wellbutrin SR.

·         Wellbutrin SR, Wellbutrin XL, and Zyban share a common strength (150 mg).  Since Wellbutrin SR and Zyban are interchangeable, we are concerned that healthcare professionals may also assume that Wellbutrin XL can be interchanged with Wellbutrin SR or Zyban.  If Wellbutrin XL is erroneously given twice daily, this could result in an increased risk of seizure to the patient.

 

Because of these concerns, DMETS recommends the creation and implementation of a risk management plan to educate healthcare professionals and patients on the appropriate use of Wellbutrin XL with respect to other marketed dosage forms of bupropion hydrochloride.

 

·         Healthcare providers will need to be informed that a new once daily extended release formulation of bupropion will be available in the US marketplace.

·         Healthcare providers will also need to be informed that there will be a 150 mg strength for Wellbutrin SR, Zyban, and Wellbutrin XL.

·         Healthcare providers need to be educated regarding how the new extended release formulation should be administered to both new and established patients, and under what circumstances the extended release products can be interchanged.

·         If healthcare providers switch a patient from Wellbutrin or Wellbutrin SR to Wellbutrin XL, the patient needs to fully understand the dosing schedule and the importance of not taking Wellbutrin XL more than once daily.

 

This plan should be implemented both before and after product launch.  In addition, once this NDA is approved, you should submit any medication error reports with Wellbutrin XL to the Agency within 15 days of their receipt by your firm, whether the error is actual or potential.

 

Finally, it is CDER policy that proposed proprietary names and their associated labels must be evaluated approximately 90 days prior to the anticipated approval of the NDA.  Since the Agency is not yet prepared to approve your application, full re-evaluation of your trademark will be necessary prior to final approval of the NDA.  To this end, please assure that a complete set of mock-up container labels and labeling are provided, featuring the proposed trademark, in your complete response to this letter.  (We also have comments and requests regarding the container labels: please see the heading Labeling, below.)

 

Chemistry, Manufacturing, and Controls (CMC)

We have completed our review of your submission and have the following comments and requests for information:

1.       Please provide a description of the bulk packaging process for the drug product.

2.       In your sampling plan for the drug product, you indicate that representative samples of the drug product will be taken at the end of the manufacturing process to serve as a source of samples for testing.  Please be advice that samples should be taken throughout the manufacturing process and not just at the end.  Please provide an updated sampling plan which adequately tests samples of product from the beginning, middle, and end of the process.

 

 

 

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