FDA Approved: AZACITIDINE — Supplemental Application (BluePoint Laboratories)

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Summary

FDA approved a supplemental application for azacitidine submitted by BluePoint Laboratories, representing a modification to the existing NDA (NDA 208216).

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Diseases / indications

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes
• Myelomonocytic Leukemia

Drugs mentioned

• AZACITIDINE (AZACITIDINE)

Snippet

SUPPL AP for AZACITIDINE (AZACITIDINE)