FDA Approved: IMATINIB MESYLATE — Original Application (BluePoint Laboratories)

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Summary

FDA approved the original application for Imatinib Mesylate from BluePoint Laboratories (ANDA078340), authorizing a generic version of the cancer drug.

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Diseases / indications

• Acute Lymphoblastic Leukemia
• Chronic Myeloid Leukemia
• Dermatofibrosarcoma Protuberans
• Eosinophilic Leukemia
• Gastrointestinal Stromal Tumor
• Hypereosinophilic Syndrome
• Systemic Mastocytosis

Drugs mentioned

• Imatinib mesylate (Imatinib)

Snippet

ORIG AP for IMATINIB MESYLATE (IMATINIB MESYLATE)