New Drug Approvals Archive
New Drug Approvals: March 2007
| March 6 | Tekturna (aliskiren) Tablets - formerly Rasilez Date of Approval: March 5, 2007 Company: Novartis Treatment for High Blood Pressure Tekturna, the first in a new class of drugs called direct renin inhibitors, is a once-daily oral therapy indicated 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 7 | Lipitor Receives FDA Approval for Five New Indications in Patients With Heart Disease |
| March 9 | Amgen Announces Update To U.S. Prescribing Information for Aranesp and Epogen |
| March 13 | Tykerb (lapatinib ditosylate) Tablets Date of Approval: March 13, 2007 Company: GlaxoSmithKline Treatment for Breast Cancer Tykerb is a kinase inhibitor indicated in combination with Xeloda (capecitabine) for the 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 14 | FDA Approves Tykerb for Advanced Breast Cancer Patients |
| March 15 | FDA Extends Marketing Exclusivity for Levaquin |
| March 19 | Soliris (eculizumab) Injection Date of Approval: March 16, 2007 Company: Alexion Pharmaceuticals, Inc. Treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH) Soliris 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 19 | FDA Approves First-of-its-Kind Drug to Treat Rare Blood Disorder |
| March 20 | New Treatment Option for Epilepsy Patients With One of the Most Debilitating Seizure Types |
| March 22 | BioImagene Receives FDA Clearance for HER2/neu Application on Pathiam Imaging Software |
| March 26 | Wyeth Receives FDA Approval for New BeneFIX Features That Provide Hemophilia B Patients a Simpler and More Convenient Preparation Process for Recombinant Factor IX |
| March 30 | Ceprotin (Protein C Concentrate (Human)) 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 |
New Drug Approvals Archive
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