FDA Approved: IMATINIB MESYLATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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Summary

FDA approved a supplemental application for imatinib mesylate from Teva Pharmaceuticals USA, Inc., under ANDA204285.

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Diseases / indications

• Acute Lymphoblastic Leukemia Philadelphia Chromosome-positive
• Chronic Myeloid Leukemia
• Dermatofibrosarcoma Protuberans
• Eosinophilic Leukemia
• Gastrointestinal Stromal Tumor
• Hypereosinophilic Syndrome
• Myeloid Lymphoid Neoplasms with Pdgfra Rearrangement
• Systemic Mastocytosis

Drugs mentioned

• Imatinib mesylate (Imatinib)

Snippet

SUPPL AP for IMATINIB MESYLATE (IMATINIB MESYLATE)