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New Drug Approvals Archive - April 2009

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April 2009

April 7

Coartem (artemether and lumefantrine) Tablets

Date of Approval: April 7, 2009
Company: Novartis
Treatment for: Malaria

Coartem (artemether and lumefantrine) is an artemisinin-based combination treatment for the treatment of malaria.

Coartem (artemether and lumefantrine) FDA Approval History

April 9

Ulesfia (benzyl alcohol) Lotion 5% - formerly Summers’ Lice Asphyxiator

Date of Approval: April 9, 2009
Company: Sciele Pharma, Inc.
Treatment for: Lice

Ulesfia (benzyl alcohol) Lotion is a non-toxic, insecticide-free head lice treatment which prevents lice from closing their spiracles (sophisticated breathing apparatus) thereby killing the lice by asphyxiation.

Ulesfia (benzyl alcohol) FDA Approval History

April 24

Simponi (golimumab) Injection

Date of Approval: April 24, 2009
Company: Centocor, Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis

Simponi (golimumab) is a human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.

Simponi (golimumab) FDA Approval History

April 29

Dysport (abobotulinumtoxinA)

Date of Approval: April 29, 2009
Company: Medicis and Ipsen
Treatment for: Cervical Dystonia, Glabellar Lines

Dysport (abobotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent for the treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain, and for the temporary improvement in the appearance of moderate to severe glabellar lines.

Dysport (abobotulinumtoxinA) FDA Approval History

April 30

Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) Tablets

Date of Approval: April 30, 2009
Company: Novartis AG
Treatment for: Hypertension

Exforge HCT is a combination of the calcium channel blocker amlodipine, the angiotensin receptor blocker valsartan, and the diuretic hydrochlorothiazide indicated for the once-daily combination treatment of hypertension.

Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) FDA Approval History

April 30

Creon (pancrelipase) Delayed-Release Capsules

Date of Approval: April 30, 2009
Company: Solvay Pharmaceuticals, Inc.
Treatment for: Pancreatic Exocrine Dysfunction

Creon (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions.

Creon (pancrelipase) FDA Approval History

May 3

Creon (pancrelipase)

Labeling Revision Approved: April 30, 2010

Creon (pancrelipase) FDA Approval History

June 14

Creon (pancrelipase)

New Dosage Form Approved: June 10, 2011

Creon (pancrelipase) FDA Approval History

May 15

Simponi (golimumab)

New Indication Approved: May 15, 2013

Simponi (golimumab) FDA Approval History

July 19

Simponi (golimumab)

New Dosage Form Approved: July 18, 2013

Simponi (golimumab) FDA Approval History