Inlyta Tablet, Film Coated
Product Images NDC 63539-044

9 FDA label images from U.s. Pharmaceuticals · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Inlyta (NDC 63539-044). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

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

FDA Label Image

Chemical Structure (Inlyta 01)

Chemical Structure (Inlyta 01)
Chemical structure of axitinib, the active ingredient in INLYTA tablets. The diagram shows the molecular arrangement of axitinib, including rings and functional groups.*
FDA Label Image

Figure 1 (Inlyta 02)

Figure 1 (Inlyta 02)
A forest plot chart showing fold change and 90% confidence intervals for Cmax and AUC of INLYTA (axitinib) under various conditions, including strong CYP3A4/5 inhibitors and inducers, antacid use, and hepatic impairment. The chart includes recommendations for dose adjustments or use avoidance based on these pharmacokinetic changes.*
FDA Label Image

Figure 2 (Inlyta 03)

Figure 2 (Inlyta 03)
A Kaplan-Meier plot showing progression-free survival probability versus time in months for two treatment groups: INLYTA (axitinib) plus Avelumab, and Sunitinib. The plot includes the number of patients at risk at various time points for each group, with a legend distinguishing the two treatment curves.*
FDA Label Image

Logo (Inlyta 04)

Logo (Inlyta 04)
A Kaplan-Meier survival curve comparing overall survival (%) over time in months between two treatment arms: INLYTA (axitinib) plus pembrolizumab and sunitinib. The plot shows survival percentages declining over about 24 months, with the INLYTA plus pembrolizumab group represented by a black line and the sunitinib group by a gray dashed line. Below the x-axis, the number of patients at risk is listed at various time points for each treatment arm.*
FDA Label Image

Principal Display Panel (5 mg Tablet Bottle Label)

Principal Display Panel (5 mg Tablet Bottle Label)
A Kaplan-Meier survival curve comparing progression-free proportions over time in months between INLYTA (axitinib) and Sorafenib. The graph shows two lines, one with solid circles representing INLYTA and another with open circles for Sorafenib, with median progression-free survival times of 6.7 and 4.7 months, respectively, and accompanying statistics including hazard ratio and confidence interval.*
FDA Label Image

Principal Display Panel (1 mg Tablet Bottle Label)

FDA Label Image

Inlyta 07

FDA Label Image

Inlyta 08

Inlyta 08
Label for Inlyta (axitinib) tablets, 5 mg strength, film-coated oral tablets. The label indicates a professional sample from Pfizer, distributed by U.S. Pharmaceuticals. The package contains 30 tablets and is marked Rx only. Storage instructions specify 20°C to 25°C with permitted excursions, and the tablets are made in Ireland.*
FDA Label Image

Inlyta 09

Inlyta 09
Label for INLYTA (axitinib) tablets, 1 mg strength, film-coated, oral dosage form. The label indicates this is a professional sample not for sale, with Pfizer logo and U.S. Pharmaceuticals as distributor. The package contains 90 tablets. Storage instructions and prescription-only status are also displayed.*

* 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.