SANDOZ — Exelon FDA Review (NDA/BLA 022083, 2016)
Novartis AG · 2016 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Sandoz's Exelon Patch (rivastigmine transdermal system) for mild to moderate Alzheimer's and Parkinson's disease dementia, including a new 13.3 mg/24 hours dosage. This approval followed review of supplemental NDAs, primarily focusing on Study D2340, which compared the 15 cm² (13.3 mg/24 hours) patch to the 10 cm² (9.5 mg/24 hours) patch. While the higher dose did not consistently meet the primary ADAS-Cog endpoint at Week 48, it showed significant improvement on ADCS-IADL at Week 48 and ADAS-Cog at Week 24. Safety data indicated expected gastrointestinal adverse events, generally mild to moderate. The review also addressed medication errors and labeling improvements.
Key findings — cited to the page
| severe skin irritation | 2.2 % | Exelon Patch · p.16 |
| severe skin irritation | 1.0 % | placebo patch · p.16 |
| Indication | For the treatment of mild to moderate dementia associated with Parkinson’s disease (PDD). | Exelon Patch · p.1 |
| New dosage strength | 13.3 mg/24 hours | Exelon Patch · p.4 |
| Approval effective date | August 31, 2012 | · p.4 |
| Indication | Mild to moderate dementia of the Alzheimer’s type | Exelon Patch · p.9 |
| Supplemental New Drug Application (sNDA) receipt date | October 31, 2011 | Exelon Patch · p.4 |
| Insomnia (10 cm group) | 4 % | Study 2340 · p.38 |
| Indication | Mild to moderate dementia associated with Parkinson’s disease | Exelon Patch · p.9 |
| Initial treatment dose | 4.6 mg/24 hours | Exelon Patch · p.9 |
| Minimum effective dose | 9.5 mg/24 hours | Exelon Patch · p.9 |
| Approval Date | August 31, 2012 | Exelon Patch · p.1 |
Source: Novartis AG ↗ · 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 Neurology library →