FABRE KRAMER — Exxua FDA Review (NDA021164, ORIG 1, 2023)
FABRE KRAMER · 2023 · FDA Review (openFDA)
Report summary
Fabre-Kramer's Exxua (gepirone ER) was approved by the FDA for adult Major Depressive Disorder (MDD) despite a history of non-approvals and concerns. While pediatric studies failed to show efficacy, and safety issues like QTc prolongation, embryotoxicity, and common adverse events (dizziness, nausea) were noted, these were deemed manageable through labeling. The FDA concluded gepirone has no abuse potential and its safety profile, though based on older data, was acceptable. Postmarketing studies are required for pregnancy/lactation, QTc, and long-term efficacy. Pharmacokinetic studies detailed its behavior across populations, and in vitro studies showed low potential for transporter-mediated drug interactions.
Key findings — cited to the page
| Established/Proper Name | Gepirone ER | · p.2 |
| Applicant | Fabre-Kramer Pharmaceuticals, Inc. | · p.2 |
| PDUFA Goal Date | September 23, 2023 | · p.2 |
| Review Completion Date | September 22, 2023 | · p.2 |
| Proposed Trade Name | Exxua | · p.2 |
| Pharmacologic Class | Antidepressant | · p.2 |
| Application Type | NDA | · p.2 |
| Application Number | 021164 | · p.2 |
| Priority or Standard | Standard | · p.2 |
| Submit Date | December 23, 2022 | · p.2 |
| Received Date | December 23, 2022 | · p.2 |
| Dosage form | Tablet | · p.2 |
Source: FABRE KRAMER ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →