New Drug Approvals Archive - May 2013

Sustiva (efavirenz )

Patient Population Altered: May 3, 2013

• Bristol-Myers Squibb Receives US FDA sNDA Approval for Use of Sustiva (efavirenz) in HIV-1 Infected Pediatric Patients

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.

• FDA Approves Merck’s Liptruzet (ezetimibe and atorvastatin), a New Product That Can Help Lower LDL Cholesterol

Liptruzet (atorvastatin and ezetimibe) FDA Approval History

Ilaris (canakinumab)

New Indication Approved: May 10, 2013

• Ilaris Approved by FDA to Treat Active Systemic Juvenile Idiopathic Arthritis

Ilaris (canakinumab) 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.

• FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD)

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.

• Arbor Pharmaceuticals Announces FDA Approval of Nymalize

Nymalize (nimodipine) FDA Approval History

Simponi (golimumab)

New Indication Approved: May 15, 2013

• FDA Approves Simponi to Treat Ulcerative Colitis

Simponi (golimumab) 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.

• FDA Approves Xofigo for Advanced Prostate Cancer

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.

• FDA Approves Tafinlar (dabrafenib) for Advanced Melanoma

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.

• FDA Approves Mekinist (trametinib) for Advanced Melanoma

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.

• Flamel Technologies Announces FDA Approval of Bloxiverz

Bloxiverz (neostigmine methylsulfate) FDA Approval History

Mekinist (trametinib)

New Indication Approved: January 9, 2014

• GSK Gains Accelerated FDA Approval for Combination Use of Mekinist (trametinib) and Tafinlar (dabrafenib)

Mekinist (trametinib) FDA Approval History

Breo Ellipta (fluticasone and vilanterol)

New Indication Approved: April 30, 2015

• FDA Approves Breo Ellipta (fluticasone furoate/vilanterol) for Asthma

Breo Ellipta (fluticasone and vilanterol) FDA Approval History