New Drug Approvals Archive - December 2013

Xiaflex (collagenase clostridium histolyticum)

New Indication Approved: December 6, 2013
Treatment for: Dupuytren's Contracture

• FDA Approves Xiaflex as First Drug Treatment for Peyronie’s Disease

Xiaflex (collagenase clostridium histolyticum) FDA Approval History

Sovaldi (sofosbuvir) Tablets

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

Sovaldi (sofosbuvir) is a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection.

• FDA Approves Sovaldi for Chronic Hepatitis C

Sovaldi (sofosbuvir) FDA Approval History

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.

• FDA Approves Anoro Ellipta to Treat Chronic Obstructive Pulmonary Disease

Anoro Ellipta (umeclidinium bromide and vilanterol) FDA Approval History

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.

• FDA Approves Tretten to Treat Rare Genetic Clotting Disorder

Tretten (coagulation factor XIII A-subunit (recombinant)) FDA Approval History

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.

• FDA Approves Orenitram (treprostinil) Extended-Release Tablets for the Treatment of Pulmonary Arterial Hypertension

Orenitram (treprostinil) FDA Approval History

Sovaldi (sofosbuvir)

Patient Population Altered: April 7, 2017

• FDA Approves Sovaldi (sofosbuvir) for Chronic Hepatitis C Infection in Pediatric Patients 12 Years and Older

Sovaldi (sofosbuvir) FDA Approval History