For hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive…. ANDA 218645, held by Aucta. Sapropterin Dihydrochloride.
As of Nov 15, 2026, ANDA 218645 (Zelvysia), held by Aucta, was first approved by FDA on Apr 29, 2025, with 0 approved supplements and 0 published complete response letters.
Zelvysia is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Zelvysia is to be used in conjunction with a Phe-restricted diet.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2025 | Original application | Approved | None posted |
| Zelvysia100MG/PACKET · for solution;oral | Sapropterin Dihydrochloride | Rx |
| Zelvysia500MG/PACKET · for solution;oral | Sapropterin Dihydrochloride | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
