New Drug Approvals Archive - December 2013
Xiaflex (collagenase clostridium histolyticum)
New Indication Approved: December 6, 2013
Sovaldi (sofosbuvir) Tablets
Date of Approval: December 6, 2013
Sovaldi (sofosbuvir) is a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection.
Anoro Ellipta (umeclidinium bromide and vilanterol)
Date of Approval: December 18, 2013
Anoro Ellipta (umeclidinium bromide and vilanterol) is a long-acting muscarinic antagonist (LAMA) and long-acting beta2 agonist (LABA) combination for the treatment of COPD.
Tretten (coagulation factor XIII A-subunit (recombinant))
Date of Approval: December 23, 2013
Tretten (coagulation factor XIII A-subunit (recombinant)) is a recombinant analogue of the human Factor XIII A-subunit for the prevention of bleeding in patients who have the rare clotting disorder congenital Factor XIII A-subunit deficiency.
Orenitram (treprostinil) Extended-Release Tablets
Date of Approval: December 20, 2013
Orenitram (treprostinil extended-release) is an oral prostacyclin for the treatment of pulmonary arterial hypertension.