Xiaflex Kit
Product Images NDC 66887-003

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Xiaflex (NDC 66887-003). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Endo Usa, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Figure 1. Kaplan-meier Plot Displaying Estimated Probability Of Remaining Recurrence-free Over Time In The Observational Study 4 Among Joints That Were Successfully Treated In A Previous Study (Xiaflex 1)

A Kaplan-Meier survival curve illustrating the probability of remaining recurrence-free over five years following successful treatment. The x-axis represents time since treatment in years, and the y-axis shows the probability of remaining recurrence-free. The graph includes a decreasing curve and numbers at risk below the x-axis at specified intervals.*

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Principal Display Panel – Single-pack Carton (Xiaflex 10)

Packaging label for XIAFLEX 0.9 mg per vial kit containing collagenase clostridium histolyticum for intralesional injection. The label states single-use vials for injection, no preservative, and storage instructions at 2°C to 8°C (36°F to 46°F). It is manufactured by Endo Pharmaceuticals and distributed by Endo Pharmaceuticals Inc. and Auxilium Pharmaceuticals, LLC.*

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Figure 2. Mean Percent Change In Penile Curvature Deformity – Study 1 (Xiaflex 2)

Line graph showing mean percentage change in penile curvature deformity over time from treatment start (Week 0) to follow-ups at Week 24 and Week 52. The graph compares XIAFLEX versus placebo, with XIAFLEX showing a larger reduction, reaching approximately -35.0%, while placebo reaches about -17.8% at Week 52.*

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Figure 3. Mean Percent Change In Penile Curvature Deformity – Study 2 (Xiaflex 3)

A line graph comparing mean percentage change in penile curvature deformity over time between XIAFLEX and placebo groups. The x-axis marks treatment cycles and follow-up weeks, while the y-axis shows percent change from 0% to -40%. The XIAFLEX group shows a steady decrease reaching -33.2%, and placebo decreases less, reaching -21.8% at week 52.*

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Figure 4. Mean Change In Patient-reported Peyronie’s Disease Bother Domain Score – Study 1 (Xiaflex 4)

A line graph comparing mean change in patient-reported PD Bother Domain Score over time between XIAFLEX and placebo. The vertical axis measures mean change with lower scores indicating less bother. Time points include Treatment Cycle 1 (Week 0), Follow-Up Week 24, and Follow-Up Week 52. The graph shows greater reduction in bother score for XIAFLEX compared to placebo at follow-ups.*

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Figure 5. Mean Change In Patient-reported Peyronie’s Disease Bother Domain Score – Study 2 (Xiaflex 5)

A line graph comparing mean change in patient-reported PD Bother Domain Scores over time for XIAFLEX and placebo groups. The horizontal axis shows time points: Treatment Cycle 1 (Week 0), Follow-Up Week 24, and Follow-Up Week 52. The vertical axis measures mean change, indicating less bother with lower scores. XIAFLEX shows greater reduction in bother scores compared to placebo at both follow-ups.*

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Figure A (Xiaflex 6)

Black and white illustration showing a close-up of two hands interacting with an elbow area. One hand grips the opposite forearm while the other is positioned near the elbow joint, possibly demonstrating a motion or clinical examination technique.*

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Figure B (Xiaflex 7)

A grayscale instructional illustration showing two hands manipulating a finger wrapped in a bandage. An arrow indicates a maneuver involving flexing or extending the finger, suggesting guidance for finger movement or treatment technique.*

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Principal Display Panel – 3 mL Vial, Sterile Diluent (Xiaflex 8)

Label for Sterile Diluent used for reconstitution of XIAFLEX only, containing 3 mL. Ingredients include 0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride. Distributed by Endo Pharmaceuticals Inc., Malvern, PA, and manufactured by Auxilium Pharmaceuticals, LLC, Malvern, PA. U.S. License No. 1816.*

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Principal Display Panel – 0.9 mg Vial, Xiaflex For Injection (Xiaflex 9)

Label for XIAFLEX 0.9 mg per vial, a collagenase clostridium histolyticum drug kit. The label indicates prescription use only and includes distributor Endo Pharmaceuticals Inc. and manufacturer Auxilium Pharmaceuticals, LLC, both located in Malvern, PA. The package also features the product NDC 66887-003-01.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.