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•The sponsor submitted a BE study (P/2002/0018) comparing highest strength 3mg XR tablet manufactured from Kalamazoo (lot #26,397) and Puerto Rico (lot #26,437) sites. The existing stability lots made in Puerto Rico in 1991 and 1992 were debossed on one side only (with tablet strength). Ninety-percent confidence interval analysis indicated that tablets manufactured at these sites were BE (90% Cl for Cmax , AUC was 98.0-110.6, 95-108.4, respectively) (Table 4-11), •Previously,; - --r-. ; the sponsor submitted dissolution profiles (pH6.0 & H20) of 3mg tablets made from both sites.

For lower strengths (0.5, 1, and 2 mg), only dissolution profiles (pH 6.0 & H20) from Puerto Rico were submitted. This reviewer has performed an f2 test comparing the dissolution profiles between the batches made from new site and the biobatches for PK/BE/pivotal efficacy trial manufactured at hydrocodone buy hydrocodone no the old site. The dissolution profiles between 2 sites for each strength are hydrocodone buy hydrocodone no similar (£2=50.98~82.9). Table 4-11 Table 44 90% Confidence Interval Analysis (Tvo one-sided Test Procedure) For Comparison of ADC,.., Cmax, and Tmax Following Administration of 3 mg XANAX XR(r) Tablet Sourced from Puerto Rico and D.8. Parameters Corrected hydrocodone buy hydrocodone no For Kean Assayed Tablet Lot Potency. (ngxhr/mL) B vs A 94.7 - 106.6 95.0- 108.4 Pass Cmax (ng/mL) B vs A 97.1 - 108.2 98.0- 110.6 Pass Tmax (hr) B vs A 31.4-144.8 75.0 - 111.3 Fail *TrcUment A ** (1) XANAX XR Tabtet 3 mg Domestic, Lot 26,319 Treatment B " (1) XANAX XR Tablet 3 mg Puerto Rican, Lot 26,437 *Reference is tbe second treatment for comparison Did the sponsor submit sufficient information to support the - - manufacturing site change? Yes, the information submitted to date --^ -* ) are sufficient to support the - manufacturing site change for all 4 strengths of XR tablets (0.5, 1, 2, and 3 mg). Hossain recommended the approval of this manufacturing site change.

Following are hydrocodone buy hydrocodone no the bases for vthe;approval of the) ^manufacturing site change: (1)BE was demonstrated for highest strength of XR tablet (3mg) made from the old site and new site.

Ninety-percent confidence interval for the log-transformed PK parameters (Cmax & AUC) fell within the recommended goal post (80-125).

(2)XR tablets manufactured at old site demonstrated dose-proportionality and dose-strength bioequivalence. Additionally, based on the SUP AC guidance published recently for modified-release solid dosage form, this reviewer has incorporated following information to support granting the biowaiver for remaining three lower strengths XR tablets (0.5, 1, and 2 mg): (3)Following dissolution profiles between the old and new sites are similar (f>50): (a) the highest strength 3mg (in water & pH6.0 phosphate buffer), and (b) three lower strengths XR tablets (0.5, 1, & 2mg) in pH6.0 phosphate buffer. This reviewer performed an £2 test comparing dissolution profiles between the old and new sites. The results are summarized in table below (Table 4-12). Note: 3mg XR tablet made in new site was not the biobatch used in the BE study comparing 3mg XR tablets made at old and new sites. Table 4-12 Dissolution profile comparison for 3 lower strengths XR tablets (0.5,1, and 2 mg) manufactured at the new and old sites 0.5mg lmg 2mg 3 mg Lot# (old site) Lot# (new site) The tablets should be taken intact; they should not be chewed, crushed, or broken.

State of Armamentarium for Indication(s) Medications currently approved for the treatment of Panic Disorder include: the benzodiazepines alprazolam (immediate-release) and clonazepam, as well as the SSRIs sertraline, paroxetine, and fluoxetine. Important Milestones in Product Development Alprazolam (XANAX IR) was the first compound to be approved by FDA for the treatment of Panic Disorder. This triazolobenzodiazepine represents a class of modified benzodiazepines characterized by the incorporation of a triazole ring in the basic benzodiazepine structure. The alprazolam tablet initially approved for the hydrocodone buy hydrocodone no treatment of Panic Disorder is an immediate-release formulation. This formulation must be taken 3 to 4 times daily, a regimen which, the sponsor states, may not be convenient or conducive to compliance for some patients.

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