Application Information

NDA 21-515

Efficacy Supplement Type SE-

Supplement Number

Drug: Wellbutrin XL (bupropion hydrochloride extended-release tablets)

Applicant: GlaxoSmithKline

RPM: Richardae Taylor for Doris Bates

HFD-120

Phone# 301-594-2850

Application Type (x) 505(b)(1) ( ) 505(b)(2)

Reference Listed Drug (NDA #, Drug name):

v      Application Classifications:

·         Review priority

(x) Standard ( ) Priority

·         Chem class (NDAs only)

3

·         Other (e.g., orphan, OTC)

v      User Fee Goal Dates

9/3/03

v      Special programs (indicate all that apply)

(x) None

Subpart H

   (21) CFR 314.510 (accelerated   

   approval)

( ) 21 CFR 314.520

    (restricted distribution)

( ) Fast Track

( ) Rolling Review

v      User Fee Information

·         User Fee

(x) Paid

·         User Fee waiver

( ) small business

( ) Public health

( ) Barrier-to-Innovation

( ) Other

·         Use Fee exception

( ) Orphan designation

( ) No-fee 505(b)(2)

( ) Other

v      Application Integrity Policy (AIP)

·         Applicant is on the AIP

( ) Yes    (x) No

·         This application is on the AIP

( ) Yes    (x) No

·         Exception for review (Center Director’s memo)

·         OC clearance for approval

v      Debarred certification: verified that qualifying language (e.g., willingly, knowingly) was not used in certification and certifications from foreign applicants are co-signed by U.S. agent.

(x) Verified

v      Patent

·         Information: Verify that patent information was submitted

(x) Verified

·         Patent certification [505(b)(2)]: Verify type of certifications submitted

21 CFR 314.50(i)(1)(i)(A)

( ) I   ( ) II   ( ) III   ( ) IV

21 CFR 314.50(i)(1)

( ) (ii)   ( ) (iii)

·         For paragraph IV certification, verify that the applicant notified the patent holder(s) of their certification that the patent(s) is invalid, unenforceable, or will not be infringed (certification of notification and document of receipt of notice).

( ) Verified

v      Exclusivity Summary (approvals only)

x