New Drug Approvals Archive

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

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

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

Simponi (golimumab) FDA Approval History

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

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.

• 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

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

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

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