For hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive…. ANDA 207685, held by Dr Reddys. Sapropterin Dihydrochloride.
As of Nov 15, 2026, ANDA 207685 (Sapropterin Dihydrochloride), held by Dr Reddys, was first approved by FDA on Jun 15, 2021, with 2 approved supplements and 0 published complete response letters.
JAVYGTOR (sapropterin dihydrochloride) 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). JAVYGTOR is to be used in conjunction with a Phe-restricted diet.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 15, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sapropterin Dihydrochloride100MG · tablet;oral | Sapropterin Dihydrochloride | Rx |
| Feb 28, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 26, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 15, 2021 | Original application | Approved |
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
