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New Drug Approvals Archive - April 2009

April 2009

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.

Read more: Coartem (artemether and lumefantrine) FDA Approval History

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.

Read more: Ulesfia (benzyl alcohol) FDA Approval History

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.

Read more: Simponi (golimumab) FDA Approval History

Dysport (abobotulinumtoxinA) Injection

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

Dysport (abobotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment of cervical dystonia, for the temporary improvement in the appearance of moderate to severe glabellar lines, for the treatment of spasticity in adults, and the treatment of lower limb spasticity in pediatric patients.

Read more: Dysport (abobotulinumtoxinA) FDA Approval History

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.

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

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.

Read more: Creon (pancrelipase) FDA Approval History

New Drug Approvals Archive