New Drug Approvals Archive - March 2007

Vaprisol (conivaptan hydrochloride)

New Indication Approved: February 28, 2007

• FDA Approves Astellas' Vaprisol for the Treatment of Hypervolemic Hyponatremia
• Vaprisol (conivaptan hydrochloride) FDA Approval History

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 Breast Cancer 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

Soliris (eculizumab) is a monoclonal antibody indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, and for the treatment of patients with atypical hemolytic uremic syndrome.

• FDA Approves Alexion's Soliris for All Patients With PNH
• 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 Glucose Control of a DPP-4 Inhibitor and Metformin in a Single Tablet
• Janumet (metformin and sitagliptin) FDA Approval History

Tykerb (lapatinib ditosylate)

New Indication Approved: January 29, 2010

• GSK's Tykerb Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer
• Tykerb (lapatinib ditosylate) FDA Approval History

Soliris (eculizumab)

New Indication Approved: September 23, 2011

• Soliris (eculizumab) Approved by FDA for All Patients with Atypical Hemolytic Uremic Syndrome (aHUS)
• Soliris (eculizumab) FDA Approval History

Janumet (metformin and sitagliptin)

New Formulation Approved: February 2, 2012

• FDA Approves Janumet XR (sitagliptin and metformin HCl extended-release) for Type 2 Diabetes, Offering the Powerful Efficacy of Janumet (sitagliptin/metformin HCl) Now Available with Once-Daily Convenience
• Janumet (metformin and sitagliptin) FDA Approval History

Soliris (eculizumab)

New Indication Approved: October 23, 2017

• FDA Approves Soliris (eculizumab) for the Treatment of Patients with Generalized Myasthenia Gravis (GMG)
• Soliris (eculizumab) FDA Approval History

Tekturna (aliskiren)

New Dosage Form Approved: November 14, 2017

• Noden Pharma Announces FDA Approval of Tekturna (aliskiren) Oral Pellets for the Treatment of Hypertension in Adults and Children 6 Years of Age and Older
• Tekturna (aliskiren) FDA Approval History