Magazine article Drug Topics

New Products

Magazine article Drug Topics

New Products

Article excerpt

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New drugs

The Food and Drug Administration (FDA) has approved UCB's Cimzia (certoiizumab), a pegylated anti-TNF monoclonal antibody, as treatment for adult patients with moderate-to-severe rheumatoid arthritis. Also, a new prefilled Cimzia syringe is available for subcutaneous self-administration by patients with moderate-to-severe Crohn's disease who have shown inadequate response to conventional therapy. For more information, visit www.cimzia.coni.

VeroScience and S2 Therapeutics have announced FDA approval of Cycloset, a dopamine agonist, for the treatment of Type 2 diabetes. Cydoset can be used as a monotherapy or as an adjunctive therapy to single or dual oral hypoglycemic-agent therapies such as sulfonylurea or metformin plus sulfonylurea (see www.veroscience.com).

Novartis announced that the FDA has approved Exforge HCT (amlodipine/valsartan/hydrochlorothiazide), a blood pressure treatment that combines three medications - the most often prescribed calcium channel blocker, angiotensin receptor blocker, and diuretic - in a single pill. The manufacturer calls it an important new option for patients who have tried taking dual combinations of these blood pressure medications without success. For more information, see wwwjiovartis.com.

The FDA has approved Fanapt tablets (iloperidone) to treat adults with schizophrenia, a chronic, severe, and disabling brain disorder. Like other atypical antipsychotics, Fanapt carries a boxed warning against off-label use to treat behavioral problems in older people with dementia-related psychosis. Fanapt is manufactured for Vanda by Patheon of Mississauga, Ontario.

New indications

Janssen has announced that the FDA has approved its supplemental new drug applications (SNDAs) for the use of Rlsp- | erdal Consta (risperidone) Long-Acting Treatment as both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of Bipolar I Disorder. Visit www.risperdalconsta.com for full prescribing information.

The FDA has approved Lilly's Symbyax capsules, combining fluoxetine (Prozac, an SSRI antidepressant) and olanzapine (Zyprexa, an atypical antipsychotic), as tfierapy for treatment-resistant depression in adults. Labeling changes to the monographs for olanzapine and fluoxetine reflect die new indication, which allows the option to prescribe the single-pill treatment or two separate medications. …

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