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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.  All stability data was within the applicants propose specifications.

 

A.      Basis for Approvability or Not-Approval Recommendation

NDA 21-515 is Approvable from a Chemistry standpoint due to chemistry, manufacturing and controls concerns related to the drug substance and the drug product as outlined in this review.

 

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 4444

 

 

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