FDA actions in brief, April 2009 (PegIntron, Rebetol, Apidra SoloSTAR, Temodar, Copaxone, Edluar)
Recent FDA approvals (through April 2009) related to PegIntron, Rebetol, Apidra SoloSTAR, Temodar, Copaxone, and Edluar
The combination of peginterferon alfa-2b (Pegintron, Schering-Plough) and ribavirin (Rebetol, Schering-Plough) has been approved for the treatment of chronic hepatitis C in patients aged ≥3 years with compensated liver disease.
A prefilled disposable pen containing insulin glulisine (rDNA origin) (Apidra SoloSTAR, Sanofi-Aventis) was approved for the improvement of glycemic control in adults and children aged ≥4 years with type 1 diabetes and in adults with type 2 diabetes.
An intravenous (IV) formulation of temozolomide (Temodar, Schering-Plough) was approved for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment and for the treatment of refractory anaplastic astrocytoma.
Zolpidem sublingual tablets (Edluar, Meda/Orexo) were approved for the short-term treatment of insomnia.
FDA Approves Subcutaneous Tecentriq to Treat Multiple Cancers
September 13th 2024Tecentriq Hybreza can be administered over seven minutes, compared with 30 to 60 minutes for IV infusion of Tecentriq. There is no word yet on when Tecentriq Hybreza will be available or what the price will be.
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FDA Warns of Liver Injury with Veozah for Hot Flashes
September 12th 2024The FDA has identified a probable case of serious drug induced liver injury that occurred in a woman in the United States who had received Veozah. The agency is requiring additional liver blood testing after starting therapy.
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