New Drug Approvals Archive

New Drug Approvals: March 2007

March 2
Vaprisol (conivaptan hydrochloride)

New Indication Approved: February 28, 2007

FDA Approves Astellas' Vaprisol for the Treatment of Hypervolemic Hyponatremia
 
March 5
Tekturna (aliskiren) Tablets - formerly Rasilez

Date of Approval: March 5, 2007

Company: Novartis

Treatment for: Hypertension

Tekturna (aliskiren) is a direct renin inhibitor indicated as a once-daily oral therapy for the treatment of high blood pressure as monotherapy or in combination with other high blood pressure medications.

Tekturna - The First New Type of High Blood Pressure Medicine In More Than a Decade - Receives Its First Approval in the US
 
March 13
Tykerb (lapatinib ditosylate) Tablets

Date of Approval: March 13, 2007

Company: GlaxoSmithKline

Treatment for: Breast Cancer

Tykerb (lapatinib) is a kinase inhibitor indicated for the combination treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.

FDA Approves Tykerb (lapatinib) in Combination With Xeloda (capecitabine) for the Treatment of Advanced or Metastatic Breast Cancer in Women Who Have Progressed on Prior Therapy
 
March 16
Soliris (eculizumab) Injection

Date of Approval: March 16, 2007

Company: Alexion Pharmaceuticals, Inc.

Treatment for: Paroxysmal Nocturnal Hemoglobinuria

Soliris (eculizumab) is a monoclonal antibody indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.

FDA Approves Alexion's Soliris for All Patients With PNH
 
March 30
Ceprotin (protein C) Injection

Date of Approval: March 30, 2007

Company: Baxter Healthcare Corporation

Treatment for: Protein C Deficiency

Ceprotin is a plasma-derived Protein C concentrate for use as replacement therapy in patients with life-threatening blood-clotting complications related to severe congenital Protein C deficiency.

Baxter Announces FDA Approval Of Ceprotin For Severe Congential Protein C Deficiency
 
March 30
Janumet (sitagliptin and metformin) Tablets

Date of Approval: March 30, 2007

Company: Merck & Co., Inc.

Treatment for: Diabetes Mellitus Type II

Janumet is a combination of the oral antihyperglycemic drugs sitagliptin and metformin indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus.

FDA Approves Janumet for Type 2 Diabetes, Offering Powerful Glucose Control of a DPP-4 Inhibitor and Metformin in a Single Tablet
 

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