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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

DateArticle
Aug 27, 2007IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma
Jul 23, 2007IDM Pharma Announces Plans to Amend New Drug Application for Mifamurtide (L-MTP-PE) for the Treatment of Patients with Osteosarcoma
May  9, 2007FDA Advisory Committee Reviews Data on IDM Pharma's Junovan (mifamurtide) for Treatment of Osteosarcoma
Apr  3, 2007IDM Pharma Inc. Announces Oncologic Drugs Advisory Committee Meeting for Junovan (Mifamurtide) Will Take Place on May 9, 2007
Dec 26, 2006IDM Pharma Announces Acceptance for Review of the NDA for Junovan (Mifamurtide)
Oct 26, 2006IDM Pharma Submits New Drug Application to the FDA for Junovan (mifamurtide) in the Treatment of Osteosarcoma

Further information

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