New Drug Approvals Archive
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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. 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 |
| February 1 | Tykerb (lapatinib ditosylate)
New Indication Approved: January 29, 2010 GSK's Tykerb Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer |
New Drug Approvals Archive
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