New from
CDER
• October
15. FDA today issued a Public Health Advisory
announcing a multi-pronged strategy to warn the public about the increased
risk of suicidal thoughts and behavior ("suicidality") in children
and adolescents being treated with antidepressant medications. More
Information.
• October
14. FDA approves four first-time generics for
Carboplatin for initial and secondary treatment of advanced ovarian cancer.
The reference listed drug is Paraplatin.
• October
13. FDA and Centocor notify healthcare
professionals of revisions to the prescribing
information for Remicade, indicated for the treatment
of rheumatoid arthritis and Crohn's disease. In
controlled studies of all TNFα-blocking agents,
including Remicade, more cases of lymphoma have been
observed among patients receiving the agents than
among control group patients.
MedWatch Safety Info.
• October
8. FDA approves first-time generic Gabapentin
for adjunctive therapy in the treatment of partial
seizures with and without secondary generalization in
adults with epilepsy.
The reference listed drug is Neurontin.
• October
8. Biogen Idec and Genentech notify healthcare
professionals of revisions to the prescribing section
of the Rituxan (rituximab) label due to reports of
Hepatitis B virus (HBV) reactivation with fulminant
hepatitis, hepatic failure, and death in some patients
with hematologic malignancies.
MedWatch Safety Info.
• October
4. FDA and King Pharmaceuticals notify
healthcare professionals of revisions to the Levoxyl
labeling, describing reports of choking, gagging,
tablets stuck in throat and dysphagia while taking
Levoxyl.
MedWatch
Safety Info.
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