NDA 21-515

WELLBUTRIN XL

 

1.1  Recommendations and Comments to Sponsor

 

The Office of Clinical Pharmacology and Biopharmaceutics (OCPB) has the following recommendations:

 

1)      The proposed in vitro dissolution specification is acceptable.

2)      The OCPB recommends some revisions of the proposed label’s text regarding CYP2B6-mediated drug interactions with SSRIs and protease inhibitors.  (Please refer to Section 3.2.3).

3)      If the Sponsor does not wish to include [blacked out]

 

Please forward the comments above and the labeling comments in Section 3.2.3 to the Sponsor.  Please also forward the following comment to the Sponsor:

 

In the approvable letter, the Office of Clinical Pharmacology and Biopharmaceutics recommended that in the future, the Sponsor should adhere to the practice of using [blacked out] for each dissolution profile.  The Sponsor has requested confirmation of the information provided in the teleconference of July 2, 2003 regarding this recommendation.  It should be noted that this is not necessary for routine QC testing (i.e. standard USP stages apply).  This recommendation refers to the number of tablets that should be tested for the data that should be submitted on pivotal biobatches in the NDA in support of setting the dissolution specifications.

 

 

Sally Usdin Yasuda, MS, PharmD

Reviewer, Neuropharmacological Drug Section, DPE I

Office of Clinical Pharmacology and Biopharmaceutics

 

Concurrence: Ramana Uppoor, PhD

                     Team Leader, Neuropharmacological Drug Section, DPE I

 

cc:     HFD-120       NDA 21-15, R. Levin

                              CSO/D. Bates

                              /Biopharm/S. Yusada

                              /TL Biopharm/R. Uppoor

         HFD-860       /DD DPEI/M. Mehta, C. Sahajwalla

 

 

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