L-MTP-PE FDA Approval Status
FDA Approved: No
Brand name: L-MTP-PE
Generic name: mifamurtide
Dosage form: Injection
Previous Name: Junovan
Company: IDM Pharma
Treatment for: Osteosarcoma
L-MTP-PE (mifamurtide) is a macrophage activator intended for the treatment of children and adolescents with non-metastatic osteosarcoma.
In August 2007, IDM Pharma, Inc. announced the receipt of a Not Approvable Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for mifamurtide had not been approved.
Development Timeline for L-MTP-PE
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