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New Drug Approvals Archive - December 2005

December 2005

December 2	Hylenex (hyaluronidase) Injection - formerly Enhanze SC Date of Approval: December 2, 2005 Company: Halozyme Therapeutics/Baxter Healthcare Corporation Treatment for: Adjuvant Agent to Enhance Drug Delivery Hylenex recombinant is a purified preparation of the enzyme recombinant human hyaluronidase, indicated for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs, for hypodermoclysis, and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Hylenex Halozyme Therapeutics/Baxter Healthcare Corporation - Treatment for Adjuvant Agent to Enhance Drug Delivery Hylenex (hyaluronidase) FDA Approval History
December 12	iPlex (mecasermin rinfabate [rDNA origin]) Injection - formerly SomatoKine Date of Approval: December 12, 2005 Company: Insmed Incorporated Treatment for: Primary IGF-1 Deficiency iPlex (mecasermin rinfabate) is the human recombinant of the naturally occurring protein complex of insulin-like growth factor-I (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3). iPlex is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. iPlex Insmed Incorporated - Treatment for Severe Primary IGF-1 Deficiency iPlex (mecasermin rinfabate [rDNA origin]) FDA Approval History
December 20	Nexavar (sorafenib) Tablets Date of Approval: December 20, 2005 Company: Bayer Pharmaceuticals Corporation/Onyx Pharmaceuticals, Inc. Treatment for: Renal Cell Carcinoma Nexavar (sorafenib) is an oral multi-kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma, liver cancer, and thyroid cancer. Nexavar Bayer Pharmaceuticals Corporation/Onyx Pharmaceuticals, Inc. - Treatment for Advanced Renal Cell Carcinoma Nexavar (sorafenib) FDA Approval History
December 23	Orencia (abatacept) Injection Date of Approval: December 23, 2005 Company: Bristol-Myers Squibb Company Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis Orencia (abatacept) is a selective T cell costimulation modulator indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis. Orencia Bristol-Myers Squibb Company - Treatment for Rheumatoid Arthritis Orencia (abatacept) FDA Approval History
December 29	Vaprisol (conivaptan hydrochloride) Injection Date of Approval: December 29, 2005 Company: Astellas Pharma US, Inc. Treatment for: Hyponatremia Vaprisol (conivaptan hydrochloride injection) is an arginine vasopressin antagonist for the treatment of euvolemic and hypervolemic hyponatremia in hospitalized patients. Vaprisol Astellas Pharma US, Inc. - Treatment for Euvolemic Hyponatremia Vaprisol (conivaptan hydrochloride) FDA Approval History
March 2	Vaprisol (conivaptan hydrochloride) New Indication Approved: February 28, 2007 FDA Approves Astellas' Vaprisol for the Treatment of Hypervolemic Hyponatremia Vaprisol (conivaptan hydrochloride) FDA Approval History
October 22	Vaprisol (conivaptan hydrochloride) New Formulation Approved: October 8, 2008 FDA Approves Astellas' Vaprisol (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia Vaprisol (conivaptan hydrochloride) FDA Approval History
July 31	Orencia (abatacept) New Formulation Approved: July 29, 2011 U.S. Food and Drug Administration Approves Subcutaneous Formulation of Orencia (abatacept), a Proven Non-Anti-TNF Biologic for Adults with Moderate to Severe Rheumatoid Arthritis Orencia (abatacept) FDA Approval History
June 5	Revlimid (lenalidomide) New Indication Approved: June 5, 2013 FDA Approves Revlimid (lenalidomide) for the Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma Revlimid (lenalidomide) FDA Approval History
November 22	Nexavar (sorafenib) New Indication Approved: November 22, 2013 FDA Approves Nexavar to Treat Metastatic Differentiated Thyroid Cancer Nexavar (sorafenib) FDA Approval History
February 18	Revlimid (lenalidomide) New Indication Approved: February 17, 2015 FDA Expands Indication for Revlimid (lenalidomide) in Combination with Dexamethasone to Include Patients Newly Diagnosed with Multiple Myeloma Revlimid (lenalidomide) FDA Approval History
February 22	Revlimid (lenalidomide) New Indication Approved: February 22, 2017 FDA Expands Indication for Revlimid (lenalidomide) as a Maintenance Treatment for Patients with Multiple Myeloma Following Autologous Hematopoietic Stem Cell Transplant (auto-HSCT) Revlimid (lenalidomide) FDA Approval History
July 6	Orencia (abatacept) New Indication Approved: June 30, 2017 Bristol-Myers Squibb’s Orencia (abatacept) Receives FDA Approval for Treatment of Active Psoriatic Arthritis in Adults Orencia (abatacept) FDA Approval History

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