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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.

Read more: Varubi (rolapitant) 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.

Read more: 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).

Read more: Durlaza (aspirin) FDA Approval History

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.

Read more: Nuwiq (antihemophilic factor (recombinant)) 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.

Read more: 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.

Read more: 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.

Read more: 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.

Read more: Tresiba (insulin degludec) FDA Approval History

New Drug Approvals Archive