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New Drug Approvals Archive - September 2015

September 2015

Varubi (rolapitant) Tablets and Injection

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 the prevention of delayed nausea and vomiting associated with emetogenic chemotherapy.

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.

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).

Humira (adalimumab)

New Indication Approved: September 10, 2015

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.

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.

Lonsurf (tipiracil hydrochloride and trifluridine) Capsules

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.

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.

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.

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