New Drug Approvals Archive

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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 (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 (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 (sorafenib) FDA Approval History

December 23

Orencia (abatacept) Injection

Date of Approval: December 23, 2005
Company: Bristol-Myers Squibb Company
Treatment for: Rheumatoid Arthritis

Orencia (abatacept) is a selective costimulation modulator indicated for the treatment of rheumatoid arthritis (RA).

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 (conivaptan hydrochloride) FDA Approval History

March 2

Vaprisol (conivaptan hydrochloride)

New Indication Approved: February 28, 2007

Vaprisol (conivaptan hydrochloride) FDA Approval History

October 22

Vaprisol (conivaptan hydrochloride)

New Formulation Approved: October 8, 2008

Vaprisol (conivaptan hydrochloride) FDA Approval History

July 31

Orencia (abatacept)

New Formulation Approved: July 29, 2011

Orencia (abatacept) FDA Approval History

June 5

Revlimid (lenalidomide)

New Indication Approved: June 5, 2013

Revlimid (lenalidomide) FDA Approval History

November 22

Nexavar (sorafenib)

New Indication Approved: November 22, 2013

Nexavar (sorafenib) FDA Approval History

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