NDA
21-515
Page
2
Following
is the approved in vitro dissolution specifications for both strengths
of Wellbutrin XL 150 mg and 300 mg tablets:
Apparatus: UPS Apparatus 1 (Basket) at 75 RPM
Medium: 900mL of 0.1N hydrochloric acid at 37±0.5°C
Specifications: 2 hours: (b)(4)
4
hours: (b)(4)
8
hours: (b)(4)
16
hours: (b)(4)
Sample size: 12 tablets for each time point in the dissolution
profile
We
have reviewed your proposed risk management plan included in the July 3, 2003
submission and overall, find your proposal to be acceptable. However, as discussed with you, we consider the
Healthcare Practitioner letters and Educational Communication Plan to be
essential components of this risk management plan and remind you of your
postmarketing commitment dated August 28, 2003. This commitment is listed below.
Educational Communication Plan: We note your agreement to
provide all components of your Education Communication Plan for Wellbutrin XL
(bupropion hydrochloride extended-release tablets) on or before December 15,
2003.
Please submit these educational materials as package
to the NDA. In additional, under 21 CFR
314.81(b)(2)(vii) and 314.8(b)(2)(viii), you should include a status summary of
this commitment in your annual report to this NDA. The status summary should include expected completion dates and
any changes in plans since the last annual report. All submissions, including supplements, relating to this
postmarketing commitment must be prominently labeled “Postmarketing Study
Protocol”, “Postmarketing Study Final Report”, or “Postmarketing Study
Correspondence.”
Finally, we recommend the following labeling revision for your companion NDA for Wellbutrin SR Tablets (NDA #20-358) to minimize potential errors with the use of Wellbutrin XL Tablets since there is a potential for confusion between the two products:
· Include “twice-a-day” text on container and carton labeling of the marketed product Wellbutrin SR Tablets (NDA 20-358). (Due to the 150 mg daily initial dosing for Wellbutrin SR Tablets, we recommend that this labeling statement be accompanied by a reference to full dosing information [e.g., “See package insert for full dosage information.’])
Patient Education
We also have the following recommendations regarding patient education and release materials:
· All patient information materials (e.g., tear-off sheets, brochures, website, etc.) should contain language that is consistent with the patient package insert (PPI).
· Healthcare providers should be encouraged to provide appropriate education regarding Wellbutrin XL Tablets to their patients, and to reinforce this information by providing the patient with a PPI. Our rationale for this recommendation is below.
With a few exceptions, PPIs are not required by law to be distributed at time of dispensing. PPIs are discretionary and usually do not accompany prescription medicines at the time of
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