Treats seizures associated with cyclin-dependent kinase-like … deficiency disorder (CDD). NDA 215904, held by Immedica Pharma. Ganaxolone.
As of Nov 14, 2026, NDA 215904 (Ztalmy), held by Immedica Pharma, was first approved by FDA on Mar 18, 2022, with 7 approved supplements and 0 published complete response letters.
ZTALMY is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.
| Oct 16, 2025 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Mar 18, 2022 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ztalmy50MG/ML · suspension;oral | Ganaxolone | RxReference drug |
| Oct 16, 2025 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Oct 16, 2025 | Supplement 13Labeling · Standard review | Approved | |
| Aug 6, 2025 | Supplement 12Labeling · Standard review | Approved | |
| Jun 21, 2023 | Supplement 3Labeling · Standard review | Approved | |
| Jun 21, 2023 | Supplement 4Labeling · Standard review | Approved | |
| Nov 9, 2022 | Supplement 1Labeling · Standard review | Approved | |
| Nov 9, 2022 | Supplement 2Labeling · Standard review | Approved | |
| Mar 18, 2022 | Original applicationNew molecular entity · Priority 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
