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CENTER IFOR DRUG EVALUATION AND RESEARCH APPROVAL PACKAGE FOR: APPLICATION NUMBER (Complete for all APPROVED original applications and generic oxycontin snorting efficacy supplements) NDA/BLA # : 21-434 Supplement Type (e.g. SE5): Supplement Number: HFD 120 Trade and generic names/dosage form: Xanax XR (alprazolam) Extended-release Tablets Applicant: Pharmacia Therapeutic Class: 3S Indication^) previously approved: n/a Each approved indication must have pediatric studies: Completed, Deferred, and/or Waived. 1 Indication #1: panic disorder Is there a full waiver for this indication (check one)? No: Please check all that apply: X Partial Waiver X Deferred Completed NOTE: More than one may apply Please proceed to Section B, Section C, and/or Section D and complete as necessary. I Section A: Fully Waived Studies Reason(s) for full waiver: Products in this class for this indication have been studied/labeled for pediatric population Disease/condition does not exist in children Too few children with disease to study There are safety concerns If studies are fully waived, then pediatric information is complete for this indication. If there is another indication, please see Attachment A. Otherwise, this Pediatric Page is complete and should be entered into DFS.

Section B: Partially Waived Studies Age/weight range being partially waived: Minkg mo.

• ' --- -They have largely rewritten the D&A section, now targeting 3-6 mg, and they have added language regarding the switch from IR to XR. Conclusions and Recommendations I believe that Pharmacia and Upjohn have submitted sufficient data to support the conclusion that Xanax XR is effective and acceptably safe in the treatment of panic disorder. I recommend that we issue the attached approval letter along with the mutually agreed upon final labeling. Orig NDA 21-434 HFD-120 HFD-120/TLaughren/RKatz/RLevin/MShin/AHomonnay DOC: MEMXXRPD.AP1 APPEARS THIS WAY ON ORIGINAL /s/ Thomas Laughren 1/15/03 12:15:03 PM MEDICAL OFFICER APPEARS THIS WAY ON ORIGINAL Review of Sponsor's Response to Approvable Letter Drug: XANAX XR (alprazolam extended release) Material Submitted: Response to Approvable Letter (N-BZ) Correspondence. Drug Category: Benzodiazepine; Anxiolytic Forms available for 0.5 mg, 1 mg, 2 mg, and 3 mg tabs proposed study In this submission, the generic oxycontin snorting sponsor has responded to the hydrocodone no prescription pharmacy Division's Approvable Letter dated-October 25, 2002. The Division had requested that the sponsor address several key issues including: 1) proposed labeling; and 2) generic oxycontin snorting potential dose-response relationships with XANAX XR.

In addition, the submission addresses biopharmaceutic and CMC issues, and it contains Regulatory Status, World Literature, and Safety updates.

The sponsor has also included proposed labeling regarding strategies for switching patients from XANAX IR to XANAX lR treatment. Dose-Response Relationship for XANAX XR The sponsor has provided useful information, which suggests that there was a relatively flat relationship between XANAX XR doses and subjects' mean responses (as measured by 7 co-primary efficacy measures) over most of the dosing range. Subgroups of subjects responded to each individual dose level within the dosing range of 1-10 mg. The majority of responders (-60%) reached final effective dosages which were in the range of 2-6 mg.

Within this dose range/ there was no evidence of an increasing response rate at successively higher doses. Because the numbers of responders with final effective doses of 1, 7, 8, 9, and 10 mg were small, it is difficult to interpret the dose- response data for these doses; however, the levels of response at these doses appear to approximate response levels observed with other doses. Since the study employed flexible dosing, it was not ideally designed to assess potential dose-response relationships. Nevertheless, the data support the conclusion that the generic oxycontin snorting study was positive based on the presence of responders throughout the complete flexible dosing range, as opposed to demonstrating efficacy primarily due to responses at higher doses (> 7 mg). B.Proposed Labeling Changes In summary, the labeling changes proposed by the sponsor are reasonable, they thoroughly address potential safety concerns, and they accurately reflect the results of the XANAX XR clinical studies under review.



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