New Drug Approvals Archive
New Drug Approvals: 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 |
| 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 |
| April 24 | Simponi (golimumab) Injection Date of Approval: April 24, 2009 Company: Centocor, Inc. Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis Simponi (golimumab) is a human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody administered once-monthly for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis |
| 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. FDA Approves Dysport for Therapeutic and Aesthetic Uses |
| 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 |
| 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 pancreatic enzyme preparation for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. Creon (pancrelipase) Delayed-Release Capsules First and Only Pancreatic Enzyme Product to Receive FDA Approval Under New Guidelines |
New Drug Approvals Archive
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