Sunitinib Malate

Treats gastrointestinal stromal tumor (GIST) after disease progression on or intolerance. ANDA 201275, held by Mylan. Sunitinib Malate.

As of Nov 15, 2026, ANDA 201275 (Sunitinib Malate), held by Mylan, was first approved by FDA on Dec 6, 2021, with 0 approved supplements and 0 published complete response letters.

First approved: Dec 6, 2021
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Sunitinib malate capsules are a kinase inhibitor indicated for:

treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.
treatment of adult patients with advanced renal cell carcinoma (RCC).
adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.
treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Dec 6, 2021	Original application	Approved	None posted

Products

4 strengths and forms


Sunitinib MalateEQ 12.5MG BASE · capsule;oral	Sunitinib Malate	Rx
Sunitinib MalateEQ 25MG BASE · capsule;oral	Sunitinib Malate	Rx
Sunitinib MalateEQ 37.5MG BASE · capsule;oral	Sunitinib Malate	Rx
Sunitinib MalateEQ 50MG BASE · capsule;oral	Sunitinib Malate	Rx

Identifiers

Application: ANDA 201275
Drugs@FDA: Overview at FDA
Company: Mylan

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters