FDA Approved: DECITABINE — Original Application (Meitheal Pharmaceuticals Inc.)

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Summary

FDA approved Meitheal Pharmaceuticals’ decitabine as an Original Application (ANDA), providing a generic injectable option. The approval covers the same indicat…

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Diseases / indications

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome

Drugs mentioned

• Decitabine (Decitabine)

Snippet

ORIG AP for DECITABINE (DECITABINE)