Treats cataplexy or excessive daytime sleepiness (EDS). NDA 214755, held by Alkermes Inc. Sodium Oxybate.
As of Nov 14, 2026, NDA 214755 (Lumryz), held by Alkermes Inc, was first approved by FDA on May 1, 2023, with 6 approved supplements and 0 published complete response letters.
LUMRYZ is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
| Oct 16, 2024 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| May 1, 2023 | Original applicationNew dosage form · Standard review | Approved |
| Lumryz4.5GM/PACKET · for suspension, extended release;oral | Sodium Oxybate | RxReference drug |
| Lumryz6GM/PACKET · for suspension, extended release;oral | Sodium Oxybate | RxReference drug |
| Lumryz7.5GM/PACKET · for suspension, extended release;oral | Sodium Oxybate | RxReference drug |
| Lumryz9GM/PACKET · for suspension, extended release;oral | Sodium Oxybate | RxReference drug |
| Nov 10, 2025 | Supplement 14Labeling · Standard review | Approved | |
| Mar 10, 2025 | Supplement 12REMS | Approved | |
| Dec 18, 2024 | Supplement 11REMS | Approved | |
| Oct 16, 2024 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Sep 26, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Oct 31, 2023 | Supplement 3REMS | Approved | |
| May 1, 2023 | Original applicationNew dosage form · Standard review | 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
