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Mozobil (plerixafor) FDA Approval History -

Mozobil Approval History. FDA Approved: Yes (First approved December 15, 2008) Brand name: Mozobil Generic name: plerixafor Company: Genzyme Corporation Treatment for: Bone Marrow Transplantation Mozobil (plerixafor) is a small molecule CXCR4 chemokine receptor antagonist used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the bloodstream for

Drug Approval Package: Mozobil (plerixa) Injection NDA 22311

Mozobil (plerixa) Injection Company: Genzyme Corporation Application No.: 022311 Approval Date: 12/15/2008. Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

Mozobil (plerixafor injection) | Official Patient Site

Welcome to the official patient site for Mozobil (plerixafor injection), an FDA-approved medication for patients living with non‐Hodgkin's lymphoma (NHL) or multiple myeloma (MM). See Important Safety Information.

Mozobil (plerixafor injection)

FDA approval of Mozobil was based on the results of two placebo-controlled clinical trials: Study 1 and Study 2. In both studies, the subjects were randomized to receive either Mozobil 0.24 mg/kg or placebo on each evening prior to apheresis. They received daily morning doses of G-CSF 10 micrograms

FDA Approves Genzyme’s Mozobil | Business Wire

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme Corporation (Nasdaq: GENZ) announced today that the U.S. Food and Drug Administration has granted marketing approval for Mozobil™ (plerixafor injection’s-Mozobil

Mozobil® (Plerixafor, AMD3100), 10 years after its

Just a decade ago, Mozobil® (also known as plerixafor, and AMD3100) was approved by the US Food and Drug Administration (FDA) for the autologous transplantation of bone marrow (BM) cells in patients with Non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM).

Mozobil® (Plerixafor, AMD3100), 10 years after its

Mozobil® (Plerixafor, AMD3100), 10 years after its approval by the US Food and Drug Administration. De Clercq E(1). Author information: (1)Rega Institute for Medical Research, Leuven, Belgium.

Clinical Policy: Plerixafor (Mozobil)

Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy – CP.CPA.09 for commercial, HIM.PHAR.21 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.

Plerixafor - National Cancer Institute

FDA label information for this drug is available at DailyMed. Use in Cancer. Plerixafor is approved to be used with granulocyte colony-stimulating factor (G-CSF) for:. Multiple myeloma.; Non-Hodgkin lymphoma (NHL).; Plerixafor helps move stem cells from the bone marrow to the bloodstream so that they can be collected, stored, and then given back to the patient in autologous stem cell

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