For hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive…. ANDA 209452, held by Dr Reddys. Sapropterin Dihydrochloride.
As of Nov 15, 2026, ANDA 209452 (Sapropterin Dihydrochloride), held by Dr Reddys, was first approved by FDA on Mar 30, 2021, with 3 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 |
|---|---|---|---|
| Mar 30, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sapropterin Dihydrochloride100MG/PACKET · for solution;oral | Sapropterin Dihydrochloride | Rx |
| Jan 24, 2025 | Supplement 8Labeling · Standard review | Approved | None posted |
| Mar 15, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 17, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 30, 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
