Eyetech Inc. and Pfizer have notified healthcare professionals of labeling changes for pegaptanib sodium injection (Macugen).
Eyetech Inc. and Pfizer have notified healthcare professionals of labeling changes for pegaptanib sodium injection (Macugen). Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported and occurred following administration of Macugen, along with several other medications used as part of the injection preparation procedure. Warnings of the potential for hypersensitivity reactions are now part of the Contraindications, Precautions, Adverse Events, and Dosage and Administration sections of the prescribing information. Macugen is indicated for the treatment of wet age-related macular degeneration and is administered once every six weeks by intravitreous injection.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
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