Notice of Approval of Products Under Voucher: Rare Pediatric Disease Priority Review Vouchers | Federal Regulations · Congress.wiki

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FDA

FDA-2018-N-1262

Notice of Approval of Products Under Voucher: Rare Pediatric Disease Priority Review Vouchers

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OPEN

Comment Period OpensApr 10, 2018

Type	Title	Posted	Comments	Status
Notice	Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; EYLEA HD (aflibercept) FR Doc: 2026-04888	Mar 13, 2026	--

Rare Pediatric Disease Priority Review Vouchers

Approval of Products under Voucher

CDER

Juluca™ (Dolutegravir and Rilpivirine)

Soliqua™ (Insulin Glargine and Lixisenatide)

Praluent® (Alirocumab)

Docket Research - 2018-190