III.             LABELING, PACKAGING, AND SAFETY RELATED ISSUES:

 

In the review of the professional and patient package insert labeling, carton labeling, and the container labels of “Wellbutrin XL”, DMETS has attempted to focus on safety issues relating to possible medication errors.  DMETS has identified areas of possible improvement, which may minimize potential user error.

 

1.       Since there is a potential for confusion between the SR and XL product, the sponsor should be encouraged to include the text “twice-a-day” on container labels and carton labeling of the marketed product Wellbutrin SR (NDA 20-358).  Due to the 150 mg daily initiation dosing for Wellbutrin SR, DMETS recommends that this labeling statement be accompanied by a reference to full dosing information, e.g., “*See package insert  for full dosage information.”

 

2.  PATIENT INFORMATION

Information about not taking Zyban or other bupropion containing products is buried in the patient information and does not stand out.  The sponsor should take measures to increase the prominence of this message by bolding or some other means.

 

IV.              RISK MANAGEMENT PLAN

 

DMETS requested the firm create and implement a risk management plan to educate healthcare professionals and patients on the appropriate use of this once daily extended-release formulation with respect to the other approved dosage formulations of bupropion hydrochloride.  This plan should be executed before and after product launch.  In addition, the sponsor was requested to submit any mediation error reports (potential and actual) associated with “Wellbutrin XL’ to the agency within 15 days of receipt.

 

In correspondence dated July 3, 2003, the sponsor responded to this request by proposing a communication program to educate healthcare professionals and patients on the appropriate use of Wellbutrin XL with respect to other marketed dosage forms of bupropion hydrochloride.  The sponsor wanted to communicate the following key messages to healthcare professionals and patients.

 

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

·         Healthcare providers need to be informed that there will be a 150 mg strength tablet for Wellbutrin SR, Zyban, and Wellbutrin XL, but that Wellbutrin XL is the only once-daily formulation of bupropion.

·         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 Wellbutrin or Wellbutrin SR formulations can be switched to the extended-release product.

 

The general components of this plan are summarized in Appendix One.  However, specific education materials were not submitted for review.  DMETS has no objections to the risk management plan proposed by the sponsor.  The sponsor should submit “Dear Health Professional” letters and educational materials to the Agency for review and comment when they become available.  The Division of Surveillance, Research, and communication Support reviewed the communication program and forwarded their comments to the Division in a July 24, 2003, memorandum.

 

 

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