L-MTP-PE 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 Status and FDA Approval Process for L-MTP-PE
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