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In addition, in some individuals, the magnitude of % change in Cmax may be quite significant (range: -34-1-84% ). These results indicate that separating XR tablet dosing from food intake maybe warranted.

Ideally, XR tablet should be taken with an empty stomach or preferably at least 1 hour before or 2 hours after a meal.

However, the pivotal efficacy trial was conducted with 1-1 Omg once daily administered at nighttime with no regard of food intake. •From a population PK analysis in literature, cigarette smoking showed a potential effect on alprazolam pharmacokinetics. Cigarette smoking was associated with a 100% increase in clearance of alprazolam as compared to non-smokers. • The information submitted to date are sufficient hydrocodone online buy to support the level 3 manufacturing site change for all 4 strengths XR tablets (0.5, 1, 2, and 3 mg). • Formulations are unchanged from those submitted in 1991 in the original - All the to-be-marketed Xanax XR tablet formulations (0.5, 1, 2 and 3 mg) are compositionally (both qualitatively and quantitatively) similar with only minor changes (in some case absence of color).

•Same final to-be-marketed Xanax XR formulations were used in all in vivo human studies (including PK, BE and efficacy) except changes including in color, a level 3 manufacturing site change, 2-sided debossing.

These changes have been shown to have no effect on the conclusions drawn from the bioavailability, bioequivalence and efficacy studies. • Overall, the bioanalytical method validation was found to be acceptable in terms of reproducibility, specificity', sensitivity, linearity, precision and accuracy.

•Previously DSI inspection was requested for 3 studies [BE of XR 3mg bid and IR (P/2002/0010); food study (P/2002/0013), BE of 1, 2, and 3mg XR(M/2000/0352)]. This reviewer agrees with sponsor's proposed individual specification for 4 different strengths and pH 6.0 phosphate buffer as medium.^Ideally, one common specification should be used for all 4 different strengths. However, in this Specific case, where a strength-dependent drug release phenomenon exists, dissolution specs has to be widened to accommodate all 4 strengths.

To justify this widening, an established in-vitro and in-vivo correlation (IVIVC) is required5. Since IVIVC was unsuccessful for XR tablet (4.7.2.1, page hydrocodone online buy 33), the dissolution specifications will be used as QC measures and different specifications for each strength are considered to be acceptable. The OCPB recommends revisions to the proposed labeling. Overall, OCPB finds the Clinical Pharmacology & Biopharmaceutics sections of NDA 21-434 acceptable. 4 QUESTION BASED REVIEW 4.1Background 4.1.1 What are som e of the historical aspects of this submission? Xanax (alprazolam) is marketed as an immediate hydrocodone online buy release (IR) oral dosage form indicated for the treatment of anxiety and panic disorders with or without agoraphobia. In 1991, hydrocodone online buy the sponsor (Upjohn Co) submitted UF * "*' _ for Xanax XR (extended-release) tablets forC -. ' -~ based on bio-studies and one positive clinical study. At that time, sponsors were required to have two controlled clinical trials that evaluated the efficacy of a new formulation of the marketed drug substance. However, the recent FDA ^ Guidance document published in 1998 entitled "Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products" indicates that the effectiveness of a new dosage form may be extrapolated from efficacy data from another dosage form when well-defined pharmacokinetic/pharmacodynamic relationships exist. In addition, if the relationship between blood concentration and response is not well understood, a single additional efficacy study can be sufficient to provide evidence of effectiveness. Mohammad Hossain reviewed this NDA and recommended that the NDA is approvable from OCPB's perspective (11729/1993, 8/5/1993). Briefly, CPB comments regarding following issues were sent to the sponsor: modify dissolution method and specifications, update labeling regarding DDIs by performing literature search, in-vitro metabolism study, explore PK/PD relationship in target population and include covariates analysis, single versus bid dosing in assessing PK/PD relationship. Furthermore, an agreement was reached for setting a common dissolution specification using water as medium for all strengths of Xanax XR.

DSI inspection was satisfactory for 3 studies [BE of XR 3mg bid and IR(P/2002/0010); food study (P/2002/0013), BE of 1, 2, and 3mg XR(M/2000/0352)].



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