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New Drug Approvals Archive - May 2013

May 2013

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.

Read more: Liptruzet (atorvastatin and ezetimibe) FDA Approval History

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, Asthma

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) and asthma.

Read more: Breo Ellipta (fluticasone and vilanterol) FDA Approval History

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.

Read more: Nymalize (nimodipine) FDA Approval History

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.

Read more: Xofigo (radium Ra 223 dichloride) FDA Approval History

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.

Read more: Tafinlar (dabrafenib) FDA Approval History

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.

Read more: Mekinist (trametinib) FDA Approval History

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.

Read more: Bloxiverz (neostigmine methylsulfate) FDA Approval History

New Drug Approvals Archive