FDA Approved: SOLIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)

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Summary

FDA approved a supplemental application for SOLIRIS (eculizumab) submitted by Alexion Pharmaceuticals, resulting in changes to the product labeling.

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Diseases / indications

• Atypical Hemolytic Uremic Syndrome
• Generalized Myasthenia Gravis
• Neuromyelitis Optica Spectrum Disorder
• Paroxysmal Nocturnal Hemoglobinuria

Drugs mentioned

• SOLIRIS (eculizumab)

Snippet

SUPPL AP for SOLIRIS (ECULIZUMAB)