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New Drug Approvals Archive - October 2014

October 2014

Akynzeo (netupitant and palonosetron) Capsules

Date of Approval: October 10, 2014
Company: Helsinn Group
Treatment for: Nausea/Vomiting -- Chemotherapy Induced

Akynzeo (netupitant and palonosetron) is a substance P/neurokinin 1 (NK1) receptor antagonist and serotonin-3 (5-HT3) receptor antagonist fixed-dose combination indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Read more: Akynzeo (netupitant and palonosetron) FDA Approval History

Harvoni (ledipasvir and sofosbuvir) Tablets

Date of Approval: October 10, 2014
Company: Gilead Sciences, Inc.
Treatment for: Chronic Hepatitis C

Harvoni (ledipasvir and sofosbuvir) is a once-daily NS5A inhibitor and nucleotide analog polymerase inhibitor fixed-dose combination for the treatment of chronic hepatitis C virus (HCV) genotype 1, 4, 5 or 6 infection.

Read more: Harvoni (ledipasvir and sofosbuvir) FDA Approval History

Lumason (sulfur hexafluoride lipid microsphere) Injectable Suspension

Date of Approval: October 10, 2014
Company: Bracco Diagnostics Inc.
Treatment for: Diagnostic

Lumason (sulfur hexafluoride lipid microsphere) is a contrast agent used for ultrasound imaging.

Read more: Lumason (sulfur hexafluoride lipid microsphere) FDA Approval History

Esbriet (pirfenidone) Capsules

Date of Approval: October 15, 2014
Company: InterMune, Inc.
Treatment for: Idiopathic Pulmonary Fibrosis

Esbriet (pirfenidone) is a TGF-beta synthesis inhibitor for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

Read more: Esbriet (pirfenidone) FDA Approval History

Ofev (nintedanib) Capsules

Date of Approval: October 15, 2014
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Idiopathic Pulmonary Fibrosis

Ofev (nintedanib) is a small molecule tyrosine kinase inhibitor (TKI) for the treatment of idiopathic pulmonary fibrosis.

Read more: Ofev (nintedanib) FDA Approval History

Sotylize (sotalol hydrochloride) Oral Solution

Date of Approval: October 22, 2014
Company: Arbor Pharmaceuticals
Treatment for: Ventricular Arrhythmia, Atrial Fibrillation, Atrial Flutter

Sotylize (sotalol hydrochloride) is an antiarrhythmic indicated for the treatment of ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with history of highly symptomatic atrial fibrillation/flutter.

Read more: Sotylize (sotalol hydrochloride) FDA Approval History

Obizur (antihemophilic factor (recombinant))

Date of Approval: October 23, 2014
Company: Baxter International Inc.
Treatment for: Hemophilia A

Obizur (antihemophilic factor [recombinant]) is an antihemophilic factor indicated for the treatment of bleeding episodes in adults with acquired hemophilia A.

Read more: Obizur (antihemophilic factor (recombinant)) FDA Approval History

Trumenba (meningococcal group B vaccine)

Date of Approval: October 29, 2014
Company: Pfizer Inc.
Treatment for: Meningococcal Meningitis Prophylaxis

Trumenba (meningococcal group B vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in adolescents and young adults.

Read more: Trumenba (meningococcal group B vaccine) FDA Approval History

Xigduo XR (dapagliflozin and metformin hydrochloride) Extended-Release Tablets

Date of Approval: October 30, 2014
Company: AstraZeneca
Treatment for: Diabetes Type 2

Xigduo XR (dapagliflozin and metformin hydrochloride) is a once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor and biguanide combination for the treatment of type 2 diabetes.

Read more: Xigduo XR (dapagliflozin and metformin hydrochloride) FDA Approval History

New Drug Approvals Archive