Marketing Exclusivity                               CONFIDENTIAL                            1                     

 

MARKETING EXCLUSIVITY

 

 

Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets

NDA 21-515

 

 

Pursuant to Sections 505(c)(3)(d)(iii) and 505(j)(4)(d)(iii) of the Federal Food, Drug and Cosmetic Act, and to Section 314.108(b)(4) of Title 21 of the Code of Federal regulations, GlaxoSmithKline does not request marketing exclusivity as this New Drug Application is supported by a pivotal bioequivalence study along with other supportive bioavailability studies; there are no new clinical investigations included in this application.

 

 

 

STAMPED: APPEARS THIS WAY ON ORIGINAL

 

 

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