New Drug Approvals Archive

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.

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.

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 (RCC), or kidney cancer.

Date of Approval: December 23, 2005

Company: Bristol-Myers Squibb Company

Treatment for: Rheumatoid Arthritis

Orencia (abatacept) is a selective costimulation modulator, which inhibits T cell (T lymphocyte) activation. Orencia is indicated for the treatment of rheumatoid arthritis (RA).

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.

New Indication Approved: February 28, 2007

New Formulation Approved: October 8, 2008