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The OCPB finds the proposed in vitro dissolution method and specifications acceptable. The OCPB recommends revisions to the proposed labeling text, the revisions are described in section 5.1, (page 3S) of the main review. 1.2Labeling Comments to the Sponsor 1.The Office of Clinical Pharmacology and Biopharmaceutics recommends revisions to the proposed labeling text, the revisions are described in Section 5 LABELING (page 38) of the main review. Similar labeling language revisions, as appropriate, should be adopted for the Xanax ER. 2.The sponsor should further affordable generic tramadol explore the ethnic-effect on the pharmacokinetics and safety/efficacy from the available sources (such as literature ic hydrocodone apap & post-marketing experience from over the 50 countries outside of U.S. that XR formulation has been marketed) and incorporate relevant information into the label. Following are the bases: (a) Ethnic differences in the alprazolam PK parameters (Cmax, AUC, Cl, tl/2) had been reported in the literature (Lin KM et al, 1988); (b) Ethnic differences in CYP3A4 enzyme activity have been reported in the literature and CYP3A4 pathway is the major route of elimination for alprazolam. 2 Table of Contents 1 EXECUTIVE SUMMARY 1 1.1 RECOMMENDATION 2 1.2 LABELING COMMENTS TO THE SPONSOR 2 2 TABLE OF CONTENTS 3 3 SUMMARY OF CPB FINDINGS 5 3.1 BACKGROUND • 5 3.2 CURRENT SUBMISSION 7 4 QUESTION BASED REVIEW 11 4. l BACKGROUND 11 4.1.1 What are some of the historical aspects of this submission?
11 4.1.2From the Agency's and sponsor's perspective, what are the changes the sponsor made since the sponsor i -' i? What new information has the sponsor submitted in current NDA since last agency's review of Xanax XR1 12 4.1.3 What is the locus of the current review? 13 4.1.4 Are the to-be-marketed XR formulations identical to the formulations submitted under 4.2 G^RALATTRIBUWS ^ 14 4-.2.1 What are the molecular formula and chemical properties of alprazolam? 14 4.2.2 What are the pharmacological properties of alprazolam? 14 4.3 CURRENTLY APPROVED FORMULATION AND generic phentermine no prescription INDICATION 14 18.104.22.168 Which Xanax formulation and indication are approved? 14 22.214.171.124 What oral dosing regimens of Xanax are ic hydrocodone apap recommended for the treatment of panic disorder? 15 4.3.2 Extended release tablet formulation 15 126.96.36.199 Why has the sponsor developed a new extended release tablet formulatiori.for oral use? 15 188.8.131.52 How is the new extended release tablet formulated and manufactured?
15 184.108.40.206Was the fi.nal-to be marketed alprazolam XR formulation used in all in vivo ic hydrocodone apap human studies? Did the sponsor submit sufficient information to support change, if any, made during the drag development? Would the changes affect the conclusions drawn from the bioavailability, bioequivalence and efficacy studies? 16 4.4GENERAL CLINICAL PHARMACOLOGY 17 4.4.1 Which types of clinical studies were performed to assess the new alprazolam XR formulation? 1 .17 4.4.2 Exposure - response relationships 18 220.127.116.11How were the exposure-response relationships of efficacy and safety evaluated for XR or IR tablet, and was there a correlation? (Hossain's & Chou's review) 18 4.4.3 Tolerance 19 18.104.22.168Has tolerance developed from alprazolam treatment? (Hossain's review: M/2000/0253, R/2002/003, P/2002/0010; R/2002/0002) 19 4.4.4 Pharmacodynamics (Safety/efficacy) of XR tablet 19 22.214.171.124Does the slow release rate of XR tablet have an effect on the pharmacodynamics (Safety/efficacy) of the compound? (Hossain's review; Pharmacometrics review: Mishina) 19 4.4.ic hydrocodone apap 5 General pharmacokinetics 20 126.96.36.199What are the PK characteristics of alprazolam following the administration of XR tablet and how do they compare to the administration of IR tablet? (Source: Hossain's review) 20 4.4.6 Dose-proportionality 22 188.8.131.52Has dose proportionality been established for the XR formulations of alprazolam within the therapeutic dose range (0.5-10mg) ? (Hossain's review: M/2000/0253; R/2002/003) 22 4.4.7 Strength equivalency 22 184.108.40.206Has the strength equivalency been demonstrated for the 4 strengths of XR tablets (0.5, l,2and3 mg) proposed for marketing?
(Hossain's review: M/2000/0352; R/2002/0001) 22 4.4.8 Sponsor proposed dosing regimen 22 220.127.116.11What is the sponsor's proposed dosing regimen for the Xanax XR formulation? 22 18.104.22.168Are plasma profiles of XR given bid completely bracketed by XR (qd) and IR (approved dosing regimen)?
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