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Sunday, June 14, 2009

Some new drug approvals in June 2009

Simponi
Pharmacological class: TNF blocker.
Active Ingredient: Golimumab 50mg/0.5mL; soln for SC inj; preservative-free.
Indication: Moderately to severely active rheumatoid arthritis (RA), in combination with methotrexate (MTX). Active psoriatic arthritis (PsA), alone or with MTX. Active ankylosing spondylitis (AS).
Company: Centocor Ortho Biotech, Inc.Justify Full

Axert approved for migraine treatment in adolescents

The FDA has approved Axert (almotriptan malate tablets, from Ortho-McNeil Janssen), a selective 5-HT1B/1D receptor agonist, for the acute treatment of migraine headache in adolescents 12-17 years of age with a history of migraine attacks lasting ≥4 hours.

Reclast approved for biennial dosing regimen to prevent female osteoporosis

The FDA has approved Reclast (zoledronic acid, from Novartis) injection for the prevention of osteoporosis in women for two years with a single dose.

Lamictal XR approved for treatment of epilepsy

GlaxoSmithKline announced that the FDA has approved Lamictal XR (lamotrigine extended-release tablets) as a once-a-day add-on therapy for epilepsy patients ≥13 years of age with partial onset seizures.

Nuvigil launched for excessive sleepiness

Nuvigil (armodafinil tablets) is now available from Cephalon in 50mg, 150mg, and 250mg dosage strengths.

Vyvanse approved for pediatric ADHD control 13 hours post-dose

Shire Pharmaceuticals has received FDA approval for a labeling change for its once-daily Attention Deficit Hyperactivity Disorder (ADHD) treatment Vyvanse (lisdexamfetamine dimesylate capsules).



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