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New Drug Approvals Archive - December 2013

See also: New Indications and Dosage Forms for December 2013

December 2013

Sovaldi (sofosbuvir) Tablets and Oral Pellets

Date of Approval: December 6, 2013
Company: Gilead Sciences
Treatment for: Chronic Hepatitis C

Sovaldi (sofosbuvir) is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of:

  • adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen.
  • pediatric patients 3 years of age and older with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin.

Anoro Ellipta (umeclidinium bromide and vilanterol)

Date of Approval: December 18, 2013
Company: GlaxoSmithKline plc (GSK) and Theravance, Inc.
Treatment for: Chronic Obstructive Pulmonary Disease

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
Company: Novo Nordisk A/S
Treatment for: Factor XIII A-Subunit Deficiency

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
Company: United Therapeutics Corporation
Treatment for: Pulmonary Hypertension

Orenitram (treprostinil extended-release) is an oral prostacyclin for the treatment of pulmonary arterial hypertension.

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