Sutent
Product Images NDC 63539-019
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Product Visual Gallery
This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sutent (NDC 63539-019). 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.
Figure 1 (Sutent 02)
This is a comparison between SUTENT and Placebo in a trial involving 207 and 105 people respectively. SUTENT showed a median of 273 weeks, while Placebo had a median of only 6.4 weeks. The Hazard Ratio was 0.33, with a 95% confidence interval of 0.23 to 0.47, and p-value less than 0.0001. A Time to Tumor Progression Probabilty graph is also included.*
Figure 2 (Sutent 03)
This is a statistical comparison of the median time in weeks that it took for the treatment with SUTENT and IFN-c to achieve 100% disease progression in 375 subjects each. SUTENT had a significantly longer median time of 47.3 weeks compared to IFN-c, which had a median time of 22.0 weeks. The hazard ratio for SUTENT compared to IFN-c was 0.42 with a 95% confidence interval between 0.32 and 0.54. The probability of these results occurring by chance was very low with a p-value less than 0.000001. The number of subjects at each time point is provided in a graph.*
Figure 3 (Sutent 04)
This text describes the median years of disease-free survival for two groups of subjects, SUTENT (N=309) and PLACEBO (N=306). The disease-free survival probability is presented as a graph with hazard ratios and confidence intervals. The number of subjects at risk in each group over time is also shown.*
Figure 4 (Sutent 05)
SUTENT has a higher probability of Progression Free Survival than Placebo, with a median of 10.2 months compared to 5.4 months respectively. The Hazard Ratio is 0.427 with 95% Confidence Interval ranging from 0.271 to 0.673. The statistical significance of the difference in survival was achieved with p=0.00018. The graph shows a higher percentage of subjects under SUTENT remaining free of progression over time.*
Logo (Sutent 06)
Logo (Sutent 07)
Principal Display Panel (50 mg Capsule Bottle Label)
This is a prescription medication called Sutent, which comes in the form of capsules. Each capsule contains 50 mg of sunitinib, which is equivalent to 66.8 mg of sunitinib malate. The medication should be stored at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F). The medicine should be dispensed in tight containers. The dosage and use information should be referred to in the accompanying prescribing information. This is a professional sample and not for sale. It is manufactured in Singapore and distributed by Pfizer Inc, NY, NY 10017, with a lot number and expiration date listed.*
Principal Display Panel (12.5 mg Capsule Bottle Label)
This is a medication called Sutent, which comes in the form of capsules. Each capsule contains 12.5mg of sunitinib, which is equivalent to 16.7mg of sunitinib malate. It is available only with a prescription. The recommended storage temperature is between 20°C to 25°C with permitted excursions between 15°C to 30°C. It must be dispensed in a tightly sealed container. The dosage and usage instructions must be provided by the prescribing physician. This professional sample is not for sale and must always be dispensed with a medication guide. The manufacturer is Pfizer Inc, NY, NY 10017, and it is distributed by U.S. Pharmaceuticals. The LOT/EXP number is not available.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.