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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 Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
