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However, FDA would be interested in Pharmacokinetic/Pharmacodynamic relationships including a full analysis of the results. • FDA prefers to have a single label for both formulations. • Based on the summary information provided, this application would likely be ativan combining neurontin tramadol filable. However, this would be a matter for review at the time of actual filing. • P&U would be i ' • It was noted that the clinical efficacy trial was conducted with once a day dosing of alprazolam XR. In order to support bid dosing with the XR, they would need to show that plasma concentrations for bid dosing with the XR fall between those with qd dosing with the XR and qid dosing with the IR. •A literature search and a synopsis of current ADME and drug-drug interaction data with aq myonlinemeds biz nasacort tramadol valtrex alprazolam should ativan combining neurontin tramadol be included in the submission. •An in vitro assessment of the metabolism of alprazolam and potential drug interactions should be done if not xanax sustained release found in literature. •Development of an in vitro - in vivo correlation of the new formulation should be included in the submission if sufficient data are available. •Electronic submission of all Clinical Pharmacology, Pharmacokinetic, and Clinical Trial studies is requested. •It was noted that the to-be-marketed XR formulation should be identical to the formulation submitted in the 1991 NDA. Post Meeting Note: P&U will submit a briefing package for the CMC section of the application. If needed, a teleconference would be scheduled for a discussion with the Division's CMC review team. Action Item: •Prepare and circulate the Meeting Minutes. Meeting Recorder Chair Concurrence APPEARS ativan combining neurontin tramadol THIS WAY ON ORIGINAL /s/ Thcrr.as Laughren 8/28/01 12:57:21 PM Signed for Russell Katz, M.D. APPEARS THIS WAY (N ORIGINAL CENTER IFOR DRUG EVALUATION AND RESEARCH APPROVAL PACKAGE FOR: APPLICATION NUMBER 21-434 Clinical Pharmacology and Biopharmaceutics Review OFFICE OF CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW '/ NDA: 21-434 Brand Name Generic Name Relevant IND/NDA Primary Reviewer Pharmacometrics Reviewer Team Leaders OCPB Division OND Division Sponsor Submission Type; Code Formulation; Strength Indication Submission Dates: 12/26/2001 01/04/2002 (amendment # 1, E-doc) 03/08/2002 (E-doc) 04/26/2002 (teleconference package, debossing) 05/02/2002 (amendment #5) 05/21/2002(amendment #7, E-doc) 09/13/02 [dissolution profile comparison (debossed Vs undebossed] Xanax Extended-release (XR) tablet Alprazolam •, - (Xanax XR, Reviewed by Mohammad Hossain, Ph.D.

j •IND ativan combining neurontin tramadol 23,179 (Xanax XR) •NDA 18,276 (Xanax IR, Immediate release tablet) Wen-Hwei Chou, Pharm.D., Ph.D.

HFD-860 HFD-120 Pharmacia & Upjohn Company 3S (new formulation) Extended release tablets: 0.5mg, lmg, 2mg and 3 mg Treatment of •- panic disorder, with or without agoraphobia A total of 23 studies (single dose, repeated dose studies) in healthy volunteers were submitted in Clinical Pharmacology and Biopharmaceutics section. In addition, the in vitro dissolution methods and specifications were evaluated. Overall, from the Clinical Pharmacology and Biopharmaceutics perspective, the sponsor had submitted sufficient information to support the approval. The proposed in vitro dissolution method and the specifications are also found to be acceptable. From the Clinical Pharmacology and Biopharmaceutics perspective, the pharmacokinetic parameters (the overall AUC, Cmax, and Cmin) following the twice daily (bid) dosing are bracketed by those from XR (qd) and IR (qid) regimens when same daily dose was administered. However, these data analyses have some limitations, i.e., the time-course of the effect was not taken into consideration. If the time-course after the dosing is considered, the steady-state alprazolam plasma concentrations following XF dosing are consistently the highest among three treatments (XR bid, XR qd , and IR qid) between the hours buy xanax onlin of 14 -24 over a 24-hour time span. However, the potential impact on the safety from these sustained higher alprazolam levels is unknown and needs to be further evaluated by the Clinical Division. The OCPB also proposes revisions to the proposed labeling text. 1.1Recommendation Overall, the Office of Clinical Pharmacology and Biopharmaceutics (OCPB) finds the Clinical Pharmacology & Biopharmaceutics sections of NDA 21-434 acceptable.



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