New Drug Approvals Archive - October 2014

Uceris (budesonide)

New Dosage Form Approved: October 8, 2014

• FDA Approves Uceris (budesonide) Rectal Foam for Ulcerative Colitis

Uceris (budesonide) FDA Approval History

Akynzeo (netupitant and palonosetron) Capsules

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

Akynzeo (netupitant and palonosetron) is an oral NK1 receptor antagonist and 5-HT3 receptor antagonist fixed-dose combination indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV).

• FDA Approves Akynzeo (netupitant and palonosetron) for Chemotherapy-Induced Nausea and Vomiting

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.

• FDA Approves Harvoni (ledipasvir and sofosbuvir) for Hepatitis C

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.

• FDA Approves Lumason Ultrasound Imaging Agent

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).

• FDA Approves Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis

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.

• FDA Approves Ofev (nintedanib) for Idiopathic Pulmonary Fibrosis

Ofev (nintedanib) FDA Approval History

Embeda (morphine sulfate and naltrexone hydrochloride)

Labeling Revision Approved: October 17, 2014

• FDA Approves Labeling with Abuse-Deterrent Features for Embeda (morphine/naltrexone)

Embeda (morphine sulfate and naltrexone hydrochloride) 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.

• Arbor Pharmaceuticals Announces FDA Approval of Sotylize

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.

• FDA Approves Obizur [Antihemophilic Factor (Recombinant)] for Acquired Hemophilia A

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.

• FDA Approves Trumenba - First Vaccine to Prevent Serogroup B Meningococcal Disease

Trumenba (meningococcal group B vaccine) FDA Approval History

Flublok (influenza vaccine)

Patient Population Altered: October 29, 2014

• Flublok Influenza Vaccine Now Approved for Adults Ages 18 and Older

Flublok (influenza 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.

• FDA Approves Xigduo XR (dapagliflozin and metformin hydrochloride) for Type 2 Diabetes

Xigduo XR (dapagliflozin and metformin hydrochloride) FDA Approval History

Harvoni (ledipasvir and sofosbuvir)

New Indication Approved: November 12, 2015

• FDA Approves New Indications for Harvoni to Include Patients with Genotypes 4, 5 and 6 HCV and Patients Co-Infected with HIV

Harvoni (ledipasvir and sofosbuvir) FDA Approval History

Harvoni (ledipasvir and sofosbuvir)

New Indication Approved: February 12, 2016

• FDA Approves Two Supplemental Indications for Harvoni in Chronic Hepatitis C Patients With Advanced Liver Disease

Harvoni (ledipasvir and sofosbuvir) FDA Approval History

Harvoni (ledipasvir and sofosbuvir)

Patient Population Altered: April 7, 2017

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

Harvoni (ledipasvir and sofosbuvir) FDA Approval History