AbbVie Inc. — Imbruvica FDA Review (NDA210563, ORIG 1, 2018)
AbbVie Inc. · 2018 · FDA Review (openFDA) · company profile →
Report summary
The FDA reviewed new tablet formulations (140mg, 280mg, 420mg, 560mg) of Ibrutinib (Imbruvica®), an oncology drug, to reduce patient pill burden and improve convenience and adherence. The review focused on bioequivalence and manufacturing data, as no new clinical efficacy or safety data were submitted. The FDA recommended approval for these new formulations.
Key findings — cited to the page
| Application Number | 210563Orig1s000 | · p.1 |
| Application Number | 210563Orig2s000 | · p.1 |
| PDUFA Goal Date | February 28, 2018 | · p.5 |
| Approval recommendation for Imbruvica® tablet formulations | approval | Imbruvica® · p.7 |
| Initial U.S. approval date for Imbruvica® | November 2013 | Imbruvica® · U.S. · p.8 |
| Accelerated approval status for MCL indication | accelerated approval | Imbruvica® · p.8 |
| Accelerated approval status for marginal zone lymphoma indication | accelerated approval | Imbruvica® · p.8 |
| Cmax decrease for 140mg dose (tablet vs capsule) | 10.2 % | · p.10 |
| Cmax decrease for 520mg dose (tablet vs capsule) | 27.7 % | · p.10 |
| Estimated post-marketing patient exposure for Ibrutinib | 33,591 person years | Ibrutinib · p.11 |
| Number of countries where Ibrutinib is approved | 70 | Ibrutinib · worldwide · p.11 |
Source: AbbVie Inc. ↗ · 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 Oncology library →