NDA 21-515

WELLBUTRIN XL

 

4.3  Recommendations

 

The Office of Clinical Pharmacology and Biopharmaceutics (OCPB) finds the proposed changes in the dissolution specifications acceptable.

 

The OCPB does not find proposed changes in the labeling regarding the potential for drug interactions acceptable, and recommends  changes that reflect this potential, identified in section 3.2.3 above.  Please forward the labeling comment to the Sponsor.

 

 

STAMPED: APPEARS THIS WAY ON ORIGINAL

 

 

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