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New Drug Approvals Archive - May 2013

See also: New Indications and Dosage Forms for 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.

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.

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.

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.

Tafinlar (dabrafenib) Capsules

Date of Approval: May 29, 2013
Company: GlaxoSmithKline
Treatment for: Melanoma - Metastatic, Non-Small Cell Lung Cancer, Thyroid Cancer

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 is also indicated, in combination with trametinib (Mekinist), for:

  • the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
  • the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
  • the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
  • the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.

Mekinist (trametinib) Tablets

Date of Approval: May 29, 2013
Company: GlaxoSmithKline
Treatment for: Melanoma - Metastatic, Non-Small Cell Lung Cancer, Thyroid Cancer

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 is also indicated, in combination with dabrafenib (Tafinlar), for:

  • the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
  • the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
  • the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
  • the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.

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.

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