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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.

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.

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 tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with:

  • Moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate
  • Active psoriatic arthritis (PsA) alone, or in combination with methotrexate
  • Active ankylosing spondylitis (AS)
  • Moderate to severe Ulcerative colitis (UC) with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy
    • inducing and maintaining clinical response
    • improving endoscopic appearance of the mucosa during induction
    • inducing clinical remission
    • achieving and sustaining clinical remission in induction responders

Dysport (abobotulinumtoxinA) Injection

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

Dysport (abobotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for:

  • the treatment of cervical dystonia in adults
  • the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age
  • the treatment of spasticity in patients 2 years of age and older.

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.

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.

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