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The drug cabozantinib is an approved and marketed drug for a type of kidney cancer. Exelixis successfully showed in clinical trials that cabozantinib is also effective for a type of liver cancer. Which type of drug marketing application will it file with the FDA for permission to market the drug for liver cancer?

-Over-the-counter drug application
-Supplemental New Drug Application
-Biologics license application
-Abbreviated new drug application
-Orphan drug application

User Ken Ma
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1 Answer

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Final answer:

Exelixis would file a Supplemental New Drug Application (sNDA) with the FDA to market cabozantinib for liver cancer after its approval for kidney cancer.

Step-by-step explanation:

To market cabozantinib for liver cancer after it has already been approved for kidney cancer, Exelixis would need to file a Supplemental New Drug Application (sNDA) with the Food and Drug Administration (FDA). An sNDA is submitted for an existing approved drug when there is a proposed change to the labeling, formulation, or dosage, or if there is a new indication for use.

Since cabozantinib is effective for a type of liver cancer and has already been approved for kidney cancer, this application is appropriate to extend its marketing to include treatment for liver cancer.

User Pushkraj Lanjekar
by
7.8k points
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