sábado, 26 de septiembre de 2020

CDER New: 9/25/2020



What's New Related to Drugs
September 24, 2020

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

September 24, 2020

Drug Name and
Application Number
Active IngredientDosage Form/ RouteSubmissionCompanySubmission ClassificationSubmission Status
Implanon
NDA #021529
EtonogestrelImplant; ImplantationSUPPL-19Organon Usa IncLabelingApproved
Implanon
NDA #021529
EtonogestrelImplant; ImplantationSUPPL-20Organon Usa IncLabelingApproved
Implanon
NDA #021529
EtonogestrelImplant; ImplantationSUPPL-19Organon Usa IncLabelingApproved
Nexplanon
NDA #021529
EtonogestrelImplant; ImplantationSUPPL-19Organon Usa IncLabelingApproved
Nexplanon
NDA #021529
EtonogestrelImplant; ImplantationSUPPL-20Organon Usa IncLabelingApproved
Nexplanon
NDA #021529
EtonogestrelImplant; ImplantationSUPPL-19Organon Usa IncLabelingApproved
Revlimid
NDA #021880
LenalidomideCapsule; OralSUPPL-54CelgeneREMSApproved
Benlysta
BLA #125370
BelimumabInjectable; InjectionSUPPL-71Human Genome Sciences Inc.EfficacyApproved

September 23, 2020

Drug Name and
Application Number
Active IngredientDosage Form/ RouteSubmissionCompanySubmission ClassificationSubmission Status
Travasol 10% In Plastic Container
NDA #018931
Amino AcidsInjectable; InjectionSUPPL-55Baxter HlthcareLabelingApproved
Travasol 5.5% In Plastic Container
NDA #018931
Amino AcidsInjectable; InjectionSUPPL-55Baxter HlthcareLabelingApproved
Travasol 8.5% In Plastic Container
NDA #018931
Amino AcidsInjectable; InjectionSUPPL-55Baxter HlthcareLabelingApproved
Prosol 20% Sulfite Free In Plastic Container
NDA #020849
Amino AcidsInjectable; InjectionSUPPL-25Baxter HlthcareLabelingApproved
Lumify
NDA #208144
Brimonidine TartrateSolution/Drops; OphthalmicSUPPL-11Bausch and Lomb IncLabelingApproved

No hay comentarios: