ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
FDA Regulatory History
| Product Name | RebyotaTM | VowstTM |
|---|---|---|
| Regulatory Events | IND submission (2013.03.21.) |
IND submission (2014.12.08.) |
| Breakthrough Designation granted (2015.10.08.) |
Breakthrough Designation granted (2015.06.11.) |
|
| Fast Track Designation granted (2013.05.21.) |
Orphan Drug Designation granted (2015.08.19.) |
|
| Orphan Drug Designation granted (2014.0.10 Amended on 2017.11.9.). |
Priority review granted (2022.10.25.) |
|
| BLA filed (2022.01.28.) |
BLA filed (2022.10.25.) |
|
| Action Due Date (2022.11.30.) |
Action Due Date (2023.04.26. |