New Drug Approvals Archive - March 2007

Tekturna (aliskiren) Tablets and Oral Pellets - 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.

• Tekturna - The First New Type of High Blood Pressure Medicine In More Than a Decade - Receives Its First Approval in the US
• Tekturna (aliskiren) FDA Approval History

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 BreastCancer in Women Who Have Progressed on Prior Therapy
• Tykerb (lapatinib ditosylate) FDA Approval History

Soliris (eculizumab) Injection

Date of Approval: March 16, 2007
Company: Alexion Pharmaceuticals, Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria, Hemolytic Uremic Syndrome, Myasthenia Gravis

Soliris is a complement inhibitor indicated for:

• the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis
• the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy
• the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive
• the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

• FDA Approves Soliris (eculizumab) for Paroxysmal Nocturnal Hemoglobinuria
• Soliris (eculizumab) FDA Approval History

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
• Ceprotin (protein C) FDA Approval History

Janumet (metformin and sitagliptin) Tablets

Date of Approval: March 30, 2007
Company: Merck & Co., Inc.
Treatment for: Diabetes Type 2

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 GlucoseControl of a DPP-4 Inhibitor and Metformin in a Single Tablet
• Janumet (metformin and sitagliptin) FDA Approval History