New Drug Approvals Archive - September 2015

Varubi (rolapitant) Tablets

Date of Approval: September 1, 2015
Company: Tesaro Inc.
Treatment for: Nausea/Vomiting -- Chemotherapy Induced

Varubi (rolapitant) is a substance P/neurokinin 1 (NK1) receptor antagonist indicated for use in combination with other antiemetic agents for the prevention of delayed nausea and vomiting associated with emetogenic chemotherapy.

• FDA Approves Varubi (rolapitant) for Chemotherapy-Induced Nausea and Vomiting

Varubi (rolapitant) FDA Approval History

Emend (aprepitant)

Patient Population Altered: August 28, 2015

• FDA Approves Pediatric Indication for Emend (aprepitant) Capsules in Combination with Other Antiemetic Agents

Brilinta (ticagrelor)

New Indication Approved: September 3, 2015

• FDA Approves Expanded Indication for Brilinta to Include Long-Term Use in Patients with a History of Heart Attack

Brilinta (ticagrelor) FDA Approval History

Xuriden (uridine triacetate) Oral Granules

Date of Approval: September 4, 2015
Company: Wellstat Therapeutics Corporation
Treatment for: Hereditary Orotic Aciduria

Xuriden (uridine triacetate) is an orally administered pyrimidine analog uridine replacement product for the treatment of patients with hereditary orotic aciduria.

• FDA Approves Xuriden (uridine triacetate) to Treat Hereditary Orotic Aciduria

Xuriden (uridine triacetate) FDA Approval History

Durlaza (aspirin) Extended Release Capsules

Date of Approval: September 4, 2015
Company: New Haven Pharmaceuticals, Inc.
Treatment for: Ischemic Stroke -- Prophylaxis

Durlaza (aspirin) is a 24-hour, extended release aspirin formulation for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack).

• FDA Approves Durlaza (aspirin) ER Capsules for Secondary Prevention of Stroke and Acute Cardiac Events

Durlaza (aspirin) FDA Approval History

Humira (adalimumab)

New Indication Approved: September 10, 2015

• FDA Approves Humira (adalimumab) for Moderate to Severe Hidradenitis Suppurativa

Nuwiq (antihemophilic factor (recombinant)) for Injection

Date of Approval: September 4, 2015
Company: Octapharma USA, Inc.
Treatment for: Hemophilia A

Nuwiq (antihemophilic factor [recombinant]) is recombinant blood coagulation factor VIII indicated for the control and prevention of bleeding episodes in patients with hemophilia A.

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

Nuwiq (antihemophilic factor (recombinant)) FDA Approval History

Spiriva Respimat (tiotropium bromide)

New Indication Approved: September 15, 2015

• FDA Approves Spiriva Respimat (tiotropium) for Maintenance Treatment of Asthma in Adults and Adolescents

Spiriva Respimat (tiotropium bromide) FDA Approval History

Vraylar (cariprazine) Capsules

Date of Approval: September 17, 2015
Company: Allergan and Gedeon Richter plc
Treatment for: Schizophrenia, Bipolar Disorder

Vraylar (cariprazine) is a dopamine D₃/D₂ receptor partial agonist atypical antipsychotic for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia.

• FDA Approves Vraylar (cariprazine) for Schizophrenia and Bipolar Disorder

Vraylar (cariprazine) FDA Approval History

Lonsurf (tipiracil hydrochloride and trifluridine) Capsules - formerly TAS-102

Date of Approval: September 22, 2015
Company: Taiho Oncology, Inc.
Treatment for: Colorectal Cancer

Lonsurf (tipiracil and trifluridine) is a thymidine phosphorylase inhibitor and nucleoside metabolic inhibitor combination indicated for the treatment of patients with metastatic colorectal cancer who are no longer responding to other therapies.

• FDA Approves Lonsurf (tipiracil and trifluridine) for Advanced Colorectal Cancer

Lonsurf (tipiracil hydrochloride and trifluridine) FDA Approval History

Ryzodeg 70/30 (insulin degludec and insulin aspart) Injection

Date of Approval: September 25, 2015
Company: Novo Nordisk
Treatment for: Diabetes Type 1, Diabetes Type 2

Ryzodeg 70/30 (insulin degludec and insulin aspart) is a long-acting insulin analog and rapid-acting human insulin analog combination indicated to improve glycemic control in adults with diabetes mellitus.

• FDA Approves Ryzodeg 70/30 (insulin degludec/insulin aspart) for Diabetes Mellitus

Ryzodeg 70/30 (insulin degludec and insulin aspart) FDA Approval History

Tresiba (insulin degludec) Injection

Date of Approval: September 25, 2015
Company: Novo Nordisk
Treatment for: Diabetes Type 1, Diabetes Type 2

Tresiba (insulin degludec) is a long-acting basal insulin analogue indicated to improve glycemic control in patients one year of age and older with diabetes mellitus.

• FDA Approves Tresiba (insulin degludec) for Diabetes Mellitus

Tresiba (insulin degludec) FDA Approval History

Betaseron (interferon beta-1b)

New Dosage Regimen: September 25, 2015

• FDA Approves Betaconnect Electronic Autoinjector for the Treatment of Relapsing-Remitting Multiple Sclerosis

Tresiba (insulin degludec)

Patient Population Altered: December 16, 2016

• Novo Nordisk Receives FDA Approval of Tresiba (insulin degludec) for Use in Children and Adolescents With Diabetes

Tresiba (insulin degludec) FDA Approval History