received "not-approvable" letter for osteosarcoma in 8/07; manufacturer to amend the current NDA with additional survival data; EU marketing approval 3/09 and available in EU 2/10
Brand Mepact (formerly known as Junovan) Generic mifamurtide (L-MTP-PE)
Company name IDM Pharma, Takeda Product type Speciality
Therapeutic category Antineoplastics Key uses Osteosarcoma
Other Uses N/A Drug Class activates macrophages to destroy cancer cells
Dosage From IV Expected Approval 2012+
FDA Filing 10/06 Last Update date February 18,2010
Link to news release