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New Drug Approvals Archive

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March 2007

March 2

Vaprisol (conivaptan hydrochloride)

New Indication Approved: February 28, 2007

Vaprisol (conivaptan hydrochloride) FDA Approval History

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 (aliskiren) FDA Approval History

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.

Tykerb (lapatinib ditosylate) FDA Approval History

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, and for the treatment of patients with atypical hemolytic uremic syndrome.

Soliris (eculizumab) FDA Approval History

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.

Ceprotin (protein C) FDA Approval History

March 30

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.

Janumet (metformin and sitagliptin) FDA Approval History

February 1

Tykerb (lapatinib ditosylate)

New Indication Approved: January 29, 2010

Tykerb (lapatinib ditosylate) FDA Approval History

September 23

Soliris (eculizumab)

New Indication Approved: September 23, 2011

Soliris (eculizumab) FDA Approval History

February 2

Janumet (metformin and sitagliptin)

New Formulation Approved: February 2, 2012

Janumet (metformin and sitagliptin) FDA Approval History

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