netupitant / palonosetron Oral Capsule
- Brand(s)
- Akynzeo
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Eisai Inc. (2015-05-21)
- Oldest Current Product
- 2014-10-13
- License(s)
- NDA
- RxNORM
- ORAL CAPSULE\NETUPITANT:PALONOSETRON
- FDAOB
- ORAL\CAPSULE\NETUPITANT: PALONOSETRON HYDROCHLORIDE
- SPL Active
- ORAL\CAPSULE\NETUPITANT: PALONOSETRON
- SPL Moiety
- ORAL\CAPSULE\NETUPITANT: PALONOSETRON
product(s) by strength(s)
netupitant 300 mg / palonosetron 0.5 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 628560796 | Akynzeo | NDA | Eisai Inc. | 2014-10-13 | NETUPITANT, PALONOSETRON | ORAL | CAPSULE | NDA205718 | 2daa0c22-3051-4f12-a860-e5404c862760 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA205718 | AKYNZEO | HELSINN HEALTHCARE SA | 2014-10-10 | p5202333, PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING, SUBSTANCE p6297375 p8623826, PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING p8951969, SUBSTANCE | NEW CHEMICAL ENTITY [2019-10-10] | NDA205718_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA205718_001 | RX | NETUPITANT (300MG), PALONOSETRON HYDROCHLORIDE (EQ 0.5MG BASE) | ORAL | CAPSULE | True | 2014-10-10 | AKYNZEO |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p5202333 (view patent) | 2015-04-13 | NDA205718, NDA021372, NDA022233 | palonosetron Injectable Solution palonosetron Oral Capsule |
| 2 | p6297375 (view patent) | 2020-02-22 | NDA205718 | |
| 3 | p8623826 (view patent) | 2030-11-18 | NDA205718 | |
| 4 | p8951969 (view patent) | 2030-11-18 | NDA205718 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 2daa0c22-3051-4f12-a860-e5404c862760 (view SPL) | These highlights do not include all the information needed to use AKYNZEO safely and effectively. See full prescribing information for AKYNZEO. AKYNZEOTM (netupitant and palonosetron) capsules, for oral use Initial U.S. Approval: 2014 | prescription | Human Prescription | Eisai Inc. | API MANUFACTURE, MANUFACTURE | 2015-05-21 | 6 | 628560796 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII