New Drug Approvals Archive - February 2009

Isentress (raltegravir)

Labeling Revision Approved: January 29, 2009

• HIV/AIDS Update - Traditional Approval of Isentress (raltegravir)

Isentress (raltegravir) FDA Approval History

ATryn (Antithrombin (Recombinant))

Date of Approval: February 6, 2009
Company: GTC Biotherapeutics, Inc.
Treatment for: Antithrombin III Deficiency

ATryn (Antithrombin (Recombinant)) is a recombinant form of human antithrombin for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.

• ATryn (Antithrombin [Recombinant]) Approved by the FDA

ATryn (Antithrombin (Recombinant)) FDA Approval History

Uloric (febuxostat) Tablets

Date of Approval: February 13, 2009
Company: Takeda Pharmaceutical Company Limited
Treatment for: Gout

Uloric (febuxostat) is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout.

• FDA Approves Uloric (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout

Uloric (febuxostat) FDA Approval History

Apidra (insulin glulisine)

New Dosage Form Approved: February 24, 2009

• FDA Approves Apidra SoloSTAR - a Prefilled Disposable Insulin Pen

Apidra (insulin glulisine) FDA Approval History

Symbicort (budesonide and formoterol)

New Indication Approved: February 27, 2009

• FDA Approves Symbicort for Chronic Obstructive Pulmonary Disease (COPD)

Symbicort (budesonide and formoterol) FDA Approval History