FDA Approved: IMATINIB MESYLATE — Original Application (Mylan Pharmaceuticals Inc.)

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Summary

FDA approved Mylan's original application for imatinib mesylate tablets, a generic version of Gleevec, for the same indications as the reference product.

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Diseases / indications

• Chronic Myeloid Leukemia
• Dermatofibrosarcoma Protuberans
• Gastrointestinal Stromal Tumor
• Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Drugs mentioned

• Imatinib mesylate (Imatinib)

Snippet

ORIG AP for IMATINIB MESYLATE (IMATINIB)