New Drug Approvals Archive

New Drug Approvals: February 2009

February 5
Isentress (raltegravir)

Labeling Revision Approved: January 29, 2009

HIV/AIDS Update - Traditional Approval of Isentress (raltegravir)
 
February 6
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
 
February 13
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
 
February 26
Apidra (insulin glulisine)

New Dosage Form Approved: February 24, 2009

FDA Approves Apidra SoloSTAR - a Prefilled Disposable Insulin Pen
 
February 27
Symbicort (budesonide and formoterol)

New Indication Approved: February 27, 2009

FDA Approves Symbicort for Chronic Obstructive Pulmonary Disease (COPD)
 

New Drug Approvals Archive

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