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New Drug Approvals Archive - December 2005

December 2005

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.

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.

Nexavar (sorafenib) Tablets

Date of Approval: December 20, 2005
Company: Bayer Pharmaceuticals Corporation
Treatment for: Renal Cell Carcinoma, Hepatocellular Carcinoma, Thyroid Cancer

Nexavar (sorafenib) is an oral multi-kinase inhibitor indicated for the treatment of hepatocellular carcinoma, renal cell carcinoma, and thyroid carcinoma.

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.

Revlimid (lenalidomide) Capsules

Date of Approval: December 27, 2005
Company: Celgene Corporation
Treatment for: Myelodysplastic Syndrome, Multiple Myeloma, Lymphoma, Follicular Lymphoma

Revlimid (lenalidomide) is a thalidomide analogue indicated for the treatment of adult patients with:

  • Multiple myeloma (MM), in combination with dexamethasone.
  • MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
  • Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
  • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
  • Previously treated follicular lymphoma (FL), in combination with a rituximab product.
  • Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.

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.

Revlimid (lenalidomide) Capsules

Date of Approval: December 27, 2005
Company: Celgene Corporation
Treatment for: Myelodysplastic Syndrome, Multiple Myeloma, Lymphoma, Follicular Lymphoma

Revlimid (lenalidomide) is a thalidomide analogue indicated for the treatment of adult patients with:

  • Multiple myeloma (MM), in combination with dexamethasone.
  • MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
  • Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
  • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
  • Previously treated follicular lymphoma (FL), in combination with a rituximab product.
  • Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.

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