New Drug Approvals Archive

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May 2013

May 3

Sustiva (efavirenz )

Patient Population Altered: May 3, 2013

May 3

Liptruzet (atorvastatin and ezetimibe) Tablets

Date of Approval: May 3, 2013
Company: Merck
Treatment for: Heterozygous Familial Hypercholesterolemia

Liptruzet (atorvastatin and ezetimibe) is a statin (HMG-CoA reductase inhibitor) and cholesterol absorption inhibitor combination indicated for the treatment of hyperlipidemia.

Liptruzet (atorvastatin and ezetimibe) FDA Approval History

May 10

Ilaris (canakinumab)

New Indication Approved: May 10, 2013

Ilaris (canakinumab) FDA Approval History

May 10

Breo Ellipta (fluticasone and vilanterol) Inhalation Powder

Date of Approval: May 10, 2013
Company: GlaxoSmithKline plc (GSK) and Theravance, Inc.
Treatment for: Chronic Obstructive Pulmonary Disease

Breo Ellipta (fluticasone and vilanterol) is a once-a-day inhaled corticosteroid/long-acting beta2 agonist (LABA) combination indicated for the treatment of patients with chronic obstructive pulmonary disease (COPD).

Breo Ellipta (fluticasone and vilanterol) FDA Approval History

May 10

Nymalize (nimodipine) Oral Solution

Date of Approval: May 10, 2013
Company: Arbor Pharmaceuticals
Treatment for: Subarachnoid Hemorrhage

Nymalize (nimodipine) is a calcium channel blocker indicated to improve neurological outcome following subarachnoid hemorrhage.

Nymalize (nimodipine) FDA Approval History

May 15

Simponi (golimumab)

New Indication Approved: May 15, 2013

Simponi (golimumab) FDA Approval History

May 15

Xofigo (radium Ra 223 dichloride) Injection

Date of Approval: May 15, 2013
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Prostate Cancer

Xofigo (radium 223 dichloride) is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer.

Xofigo (radium Ra 223 dichloride) FDA Approval History

May 29

Tafinlar (dabrafenib) Capsules

Date of Approval: May 29, 2013
Company: GlaxoSmithKline
Treatment for: Melanoma - Metastatic

Tafinlar (dabrafenib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

Tafinlar (dabrafenib) FDA Approval History

May 29

Mekinist (trametinib) Tablets

Date of Approval: May 29, 2013
Company: GlaxoSmithKline
Treatment for: Melanoma - Metastatic

Mekinist (trametinib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.

Mekinist (trametinib) FDA Approval History

May 31

Bloxiverz (neostigmine methylsulfate) Injection

Date of Approval: May 31, 2013
Company: Flamel Technologies
Treatment for: Reversal of Nondepolarizing Muscle Relaxants

Bloxiverz (neostigmine methylsulfate) is a cholinesterase inhibitor used for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.

Bloxiverz (neostigmine methylsulfate) FDA Approval History

January 9

Mekinist (trametinib)

New Indication Approved: January 9, 2014

Mekinist (trametinib) FDA Approval History

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