NEWS FROM USA
NDA Approvals
|
APPROVAL DATE |
DRUG |
COMPANY |
BRAND NAME |
PRESS RELEASE IF AVAILABLE |
|
31 Aug 2018 |
Clobazam Film Oral |
Aquestive Therapeutics |
Sympazan |
|
USFDA INSPECTIONS
|
COMPANY |
FACILITY/ LOCATION |
NEWS |
|
Lupin |
Tarapur API facility, India |
Lupin’s Tarapur API Manufacturing Facility Inspected by USFDA |
Other news from the USA
Janssen Submits Esketamine Nasal Spray NDA to USFDA for Treatment-Resistant Depression
PDUFA dates for SEP 2018
|
DATE |
DRUG |
COMPANY |
|
07 Sep 2018 |
Mepolizumab |
GSK |
|
16 Sep 2018 |
Fremanezumab |
Teva Pharma |
|
28 Sep 2018 |
Alis |
INSMED |
|
29 Sep 2018 |
Xyosted |
Antares Pharma |
|
30 Sep 2018 |
Galcanezumab |
Eli Lilly |
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