FDA Approved: IMATINIB — Supplemental Application (Dr.Reddy's Laboratories Inc)

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Summary

FDA approved a supplemental application for Imatinib from Dr. Reddy's Laboratories Inc, resulting in regulatory approval for a change to the generic product.

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Diseases / indications

• Acute Lymphoblastic Leukemia
• Chronic Myeloid Leukemia
• Dermatofibrosarcoma Protuberans
• Eosinophilic Leukemia
• Gastrointestinal Stromal Tumor
• Hypereosinophilic Syndrome
• Myelodysplastic Myeloproliferative Diseases with Eosinophilia
• Systemic Mastocytosis

Drugs mentioned

• Imatinib (imatinib)

Snippet

SUPPL AP for IMATINIB (IMATINIB)