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 Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
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