BORTEZOMIB | N205004 | FRESENIUS KABI USA LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2013-03-22 | Terminated 2014-04-14 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Millennium Pharmaceuticals, Inc. FDA-2017-P-3672 · 21 docket documents Millennium Pharmaceuticals, Inc. filed this Section 505(q) citizen petition on June 8, 2017, requesting that the FDA refrain from approving any ANDA or 505(b)(2) bortezomib product for multiple myeloma or mantle cell lymphoma with labeling that omits protected safety and efficacy information, identi | 505(q) | 2017-06-13 | Denied | Millennium Pharmaceuticals, Inc. |
Millennium Pharmaceuticals, Inc. - Citizen Petition FDA-2013-P-0998 · 3 docket documents Millennium Pharmaceuticals, Inc. filed a citizen petition under Section 505(q) of the Federal Food, Drug, and Cosmetic Act on August 12, 2013, challenging Fresenius Kabi USA's 505(b)(2) new drug application for a bortezomib injectable formulation containing boric acid and glycine instead of the mann | 505(q) | 2013-09-12 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8962572 | Nov 3, 2032 | — | — | Yes | — | — |