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 |
New Drug Approvals Archive
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