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Pharmaceuticals / Submissions and Approvals

FDA Approves Regeneron’s CMC Prior-Approval Supplement for AMD Injection

Aug. 19, 2019
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The FDA approved Regeneron’s chemistry, manufacturing and controls prior-approval supplement for its prefilled syringe for Eylea (aflibercept), a targeted therapy for age-related macular degeneration, diabetic retinopathy and macular edema.

The single-dose, two milligram sterilized syringe provides a new way of administering the medication that involves fewer steps. The product is projected to hit U.S. pharmacy shelves this year.

Eylea is designed to halt the growth of new blood vessels and hamper the ability of fluid to pass through blood vessels in the eye.

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