FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

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Summary

FDA approves a supplemental NDA for GLEEVEC (imatinib mesylate) filed by Novartis Pharmaceuticals Corporation, resulting in changes to the product labeling.

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Diseases / indications

• Acute Lymphoblastic Leukemia
• Chronic Myeloid Leukemia
• Dermatofibrosarcoma Protuberans
• Gastrointestinal Stromal Tumor

Drugs mentioned

• Gleevec (Imatinib)

Snippet

SUPPL AP for GLEEVEC (IMATINIB MESYLATE)