New Drug Approvals Archive

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 - 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

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 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

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