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New Drug Approvals Archive - February 2009

February 2009

February 5

Isentress (raltegravir)

Labeling Revision Approved: January 29, 2009

Isentress (raltegravir) FDA Approval History

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)) FDA Approval History

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.

Uloric (febuxostat) FDA Approval History

February 26

Apidra (insulin glulisine)

New Dosage Form Approved: February 24, 2009

Apidra (insulin glulisine) FDA Approval History

February 27

Symbicort (budesonide and formoterol)

New Indication Approved: February 27, 2009

Symbicort (budesonide and formoterol) FDA Approval History

New Drug Approvals Archive