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FDA Corrects Notice on Pediatric Safety Reviews


Federal Register Notice: FDA is correcting an 8/12 Federal Register notice on the Pediatric Advisory Committee meeting scheduled to discuss pediatric-focused safety reviews (80 FR 48325). Phenylephrine Hydrochloride was incorrectly linked to Durezol (difluprednate ophthalmic emulsion) 0.05% because they were both listed as item number 1 in the numbered list of products to be discussed at the meeting. Phenylephrine Hydrochloride Ophthalmic Solution is a separate stand-alone drug that will be reviewed by the committee and should be listed as item number 2. To view this notice, click here.