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Chemistry Assessment Section

 

The applicant has requested a [blacked out] expiry for the 150 and 300 mg tablets in the 7 and 30 bottles.  The applicant provided 6 months of accelerated (40°C/75% RH) stability data together with 12 months of long term (30°C/60% RH) and intermediate (30°C/60% RH) stability data on six [blacked out] batches of the drug product in each of the proposed commercial packages.  The applicant updated the dissolution specification from the original submission.    The original dissolution specifications were 2 hours: [blacked out]; 4 hours: [blacked out]; 8 hours [blacked out] and 16 hours [blacked out].  The new dissolution specifications are 2 hours: [blacked out]; 4 hours: [blacked out]; 8 hours [blacked out] and 16 hours [blacked out].  Based on the new dissolution specification, there were s[blacked out] at the 8 hour time point at 30°C/60% RH and 40°C/75% RH (see stability section of this review).  Based on the information provided in this application, the applicant has not provide [provided] enough data to support a [blacked out] expiry.  The applicant will be granted an [a] 12 month expiry for the 150 and 300 mg tablets in the 7 and 30 bottles.

 

C.      Basis for Approvability or Not-Approval Recommendation

NDA 21-515 is recommended for approval from a CMC standpoint.

 

III.             Administrative

 

A.     Reviewer’s Signature

 

 

B.     Endorsement Block

SMCLamore/Date

TOliver (TL)/Date

A (PM)/Date

 

C.     CC Block

Orig. NDA 21-515

HFD-120/Division File

HFD-DBates

HFD-120/SMCLamore

HFD-120/TOliver

 

 

 

Page 9 of 16

 

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