ILOPERIDONE | A206890 | LUPIN LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Vanda Pharmaceuticals, Inc. FDA-2016-P-2654 · 8 docket documents Vanda Pharmaceuticals Inc. filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner refrain from approving any abbreviated new drug application referencing Fanapt (iloperidone) until May 26, 2019, when three-year exclusivity ex | 505(q) Stay Request | 2016-09-08 | Denied | Vanda Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.