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

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Summary

FDA approved a supplemental application from Mylan Pharmaceuticals for imatinib mesylate, enabling a generic version to be marketed under ANDA204644.

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Diseases / indications

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

Drugs mentioned

• Imatinib mesylate (Imatinib)

Snippet

SUPPL AP for IMATINIB MESYLATE (IMATINIB)