TERIFLUNOMIDE | A209555 | NATCO PHARMA LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Sanofi-Aventis U.S. LLC et al v. Alvogen Pine Brook LLC 2 patentsANDA 209555teriflunomide | D. Del. | 2016-12-22 | Terminated 2018-01-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Kaylin Bower FDA-2026-P-1223 · 12 docket documents Kaylin Bower filed this citizen petition requesting that the FDA revise the labeling for Aubagio (teriflunomide) to clearly disclose that the statistically significant reduction in disability progression demonstrated in the pivotal TEMSO trial (Study 1) was observed only in the Eastern European tria | 505(q) | 2026-02-05 | Open | Kaylin Bower |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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