New Drug Approvals Archive
Labeling Revision Approved: January 29, 2009
ATryn (Antithrombin (Recombinant))
Date of Approval: February 6, 2009
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.
Uloric (febuxostat) Tablets
Date of Approval: February 13, 2009
Uloric (febuxostat) is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout.
Apidra (insulin glulisine)
New Dosage Form Approved: February 24, 2009
Symbicort (budesonide and formoterol)
New Indication Approved: February 27, 2009