For hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive…. ANDA 216797, held by Aurobindo Pharma. Sapropterin Dihydrochloride.
As of Nov 15, 2026, ANDA 216797 (Sapropterin Dihydrochloride), held by Aurobindo Pharma, was first approved by FDA on Jun 9, 2025, with 0 approved supplements and 0 published complete response letters.
Sapropterin dihydrochloride tablets are 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). Sapropterin dihydrochloride tablets are to be used in conjunction with a Phe-restricted diet.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 9, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sapropterin Dihydrochloride100MG · tablet;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
