APIXABAN | N220073 | BRISTOL MYERS SQUIBB CO
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2015-01723 | 6967208 | IPR | Coalition for Affordable Drugs IX, LLC et al. | Institution Denied | 2015-08-13 | — |
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3, SUPPLEMENT TO ANDA - Proposed Prescribing Information for Apix... FDA-2016-P-3463 Axinn, Veltrop & Harkrider LLP filed a suitability petition regarding proposed prescribing information for apixaban tablets as a supplement to an Abbreviated New Drug Application, seeking FDA review and approval of the proposed labeling for this generic anticoagulant product. | Suitability | 2016-10-25 | Withdrawn | Axinn, Veltrop & Harkrider LLP |
| Suitability | 2016-10-21 | Withdrawn | Axinn, Veltrop & Harkrider LLP | |
Attachment 1 FDA Orange Book page for Eliquis® (apixaban) tablets, 2.5 mg and... FDA-2016-P-3463 The law firm Axinn, Veltrop & Harkrider LLP filed a petition regarding Eliquis (apixaban) tablets in 2.5 mg and 5 mg strengths, requesting determination of suitability for abbreviated new drug application (ANDA) approval based on the Orange Book listing for this anticoagulant product. | Suitability | 2016-10-21 | Withdrawn | Axinn, Veltrop & Harkrider LLP |
Citizen Petition from David Cundiff FDA-2015-P-3408 David Cundiff filed this citizen petition under 21 U.S.C. Section 355(e)(3) and 21 C.F.R. 10.30 requesting that the FDA designate all anticoagulants including heparin, low molecular weight heparins, fondaparinux, warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban as contraindicated for patien | Other | 2015-10-26 | Denied | David Cundiff |
Citizen Petition from David K Cundiff FDA-2015-P-3410 David K. Cundiff filed this petition under the Federal Food, Drug, and Cosmetic Act section 355(e)(3) on September 25, 2015, requesting that the FDA withdraw approval and designate all oral anticoagulants including warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban as contraindicated for non- | Other | 2015-10-07 | Denied | David K Cundiff |
Citizen Petition from David K. Cundiff, MD FDA-2015-P-2373 David K. Cundiff, MD filed this petition under 21 U.S.C. Section 355(e)(3) requesting that the FDA revoke approval and add contraindication labels for all anticoagulant drugs including heparin, warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban for the treatment of venous thromboembolism (dee | Other | 2015-07-14 | Denied | David K. Cundiff, MD |
Source: Regulations.gov. FDA citizen petitions matched by application number.