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New Drug Approvals Archive - April 2009

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 receives FDA approval becoming first artemisinin-based combination treatment (ACT) for malaria in the US 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. Sciele Pharma Announces FDA Approval of Benzyl Alcohol Lotion 5%, First Prescription Non-Neurotoxic Head Lice Treatment 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) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Simponi (golimumab) FDA Approval History
April 29	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. FDA Approves Dysport (abobotulinumtoxinA) for Cervical Dystonia and 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. FDA approves Exforge HCT - the only high blood pressure treatment to combine three medications in a single pill 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) Delayed-Release Capsules First and Only Pancreatic Enzyme Product to Receive FDA Approval Under New Guidelines Creon (pancrelipase) FDA Approval History
May 3	Creon (pancrelipase) Labeling Revision Approved: April 30, 2010 Abbott Receives FDA Approval for Creon to Include Dosing Information for Patients With Chronic Pancreatitis and Pancreatectomy Creon (pancrelipase) FDA Approval History
June 14	Creon (pancrelipase) New Dosage Form Approved: June 10, 2011 Abbott Receives FDA Approval for Creon (pancrelipase) Infant-Specific Dosage for Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis Creon (pancrelipase) FDA Approval History
May 15	Simponi (golimumab) New Indication Approved: May 15, 2013 FDA Approves Simponi to Treat Ulcerative Colitis Simponi (golimumab) FDA Approval History
July 19	Simponi (golimumab) New Dosage Form Approved: July 18, 2013 Simponi Aria (golimumab) for Infusion Receives FDA Approval for Treatment of Moderately to Severely Active Rheumatoid Arthritis Simponi (golimumab) FDA Approval History
July 17	Dysport (abobotulinumtoxinA) New Indication Approved: July 16, 2015 Ipsen Announces FDA Approval of Dysport (abobotulinumtoxinA) for Upper Limb Spasticity Dysport (abobotulinumtoxinA) FDA Approval History
August 1	Dysport (abobotulinumtoxinA) New Indication Approved: July 27, 2016 Ipsen Biopharmaceuticals, Inc. Announces FDA Approval of Dysport (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Pediatric Patients Aged Two and Older Dysport (abobotulinumtoxinA) FDA Approval History
June 16	Dysport (abobotulinumtoxinA) New Indication Approved: June 14, 2017 Ipsen Announces FDA approval of Dysport (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults Dysport (abobotulinumtoxinA) FDA Approval History

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