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6.A literature search and a synopsis of current ADME and drug-drug interaction data with alprazolam must be included in the submission. 7.An in vitro assessment ioffer com si meridia phentermine of the metabolism of alprazolam and potential drug-drug interaction data with alprazolam must be included in the submission. 8.Development of an in vitro-in vivo correlation of the new formulation should be included in the submission if sufficient data are available. 9.Electronic submission of all clinical pharmacology, pharmacokinetic, and clinical trials studies was requested. 10.The proposed XANAX XR formulation must be identical to the formulation submitted in the 1991 NDA. US Regulatory History of XANAX XR Division of Neuropharmacological Drug Products Date Summary hydrocodone buy of Events February 14, 1991 Upjohn met with the Division to discuss the proposed NDA for XANAX XR Tablets; The Division suggested a biopharmaceutic is tramadol approach as an alternative to clinical data as the primary support for the extended release formulation. April 8, 1991 hydrocodone aspirin & May 29, 1991 Upjohn submitted letters to the Division providing a description bf the biopharmaceutic studies to be used as primary support of the XANAX XR NDA. August 27, 1991 Upjohn submitted --" for XANAX XR Tablets extended-release dosage form of alprazolam. The therapeutic indications included; -- February 28,1995 Upjohn; 'the XANAX XR Tablets NDA when it became apparent that the Division s the application. May, 1998 FDA issued final "Guidance for Industry, Providing Evidence of Effectiveness for Human Drug and Biological Products." July 19,2001 Pharmacia met with the Division to discuss a proposed NDA for XANAX XR Tablets (alprazolam extended-release tablets) based on a single, well-controlled efficacy study. The Division indicated that this approach would be acceptable. October 1,2001 Pharmacia submitted a hydrocodone buy Proposed Pediatric Study Request October 2,2001 Pharmacia submitted a request for Deferral of Pediatric Studies for proposed NDA 21-434. II. Clinically Relevant Findings from Biopharmaceutics and the Division of Scientific Investigations A. Biopharmaceutiic Findings -"-.- the sponsor has provided data that appear to demonstrate that plasma concentrations with twice daily dosing of alprazolam XR fall between those with once daily dosing with alprazolam XR and QID dosing with the immediate release formulation of alprazolam. The figure below illustrates the sponsor's findings.

However, it should be noted that the final review of the Biopharmaceutics Consultant is not available as of this review. Plasma alprazolam concentrations following administration of alprazolam XR tablets once daily (study 0002) and twice daily (study 0010) and hydrocodone buy alprazolam CT tablets four times daily (studies 0002 and 0010) in healthy volunteers - XANAX XH -a-' XAHAX -A- XANAX XR -A- XAHAX UmOID dmBID UBOOIB The plot shows tkit plasma concentration profiles from hydrocodone buy the IR tablets from the two studies are virtually superimposable, supporting the validity of the correction factor used The alprazolam concentration-time profile following twice daily administration of the XR tablets is within the Cmax to Cmin range for die once daily XR administration and four times daily IR administration.



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