Celgene Gets Approvable Letter for sNDA for Thalomid®
Celgene Gets Approvable Letter for sNDA for Thalomid®
A supplemental new drug application (sNDA) has been deemed “approvable” by the Food and Drug Administration for Celgene’s Thalomid (thalidomide). The sNDA includes Thalomid for the initial treatment of multiple myeloma.
The sNDA approvable letter was based on results from a large phase III study that directly compared Thalomid plus dexamethasone to dexamethasone alone as initial therapy for multiple myeloma.
Thalomid is known to have anti-angiogenic properties as well as immune modulatory effects.
A supplemental new drug application (sNDA) has been deemed “approvable” by the Food and Drug Administration for Celgene’s Thalomid (thalidomide). The sNDA includes Thalomid for the initial treatment of multiple myeloma.
The sNDA approvable letter was based on results from a large phase III study that directly compared Thalomid plus dexamethasone to dexamethasone alone as initial therapy for multiple myeloma.
Thalomid is known to have anti-angiogenic properties as well as immune modulatory effects.
posted by Bill Austin - Celgene Gets Approvable Letter for sNDA for Thalomid®
0 Comments:
Post a Comment
Links to this post:
Create a Link
<< Home