New products: April 14, 2008


Brief descriptions of over-the-counter, home health, brand, and generic drug



ArcalystInjection (rilonacept) for subcutaneous use, from Regeneron,, has received FDA approval. The interleukin-1 blocker is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes, including Familial Cold Auto-inflammatory Syndrome, and Muckle-Wells Syndrome in adults and children 12 and older.


Abbott,, has received a couple of new approvals recently. Humira (adalimumab) is now approved as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older. Simcor is a fixed-dose combination of Niaspan (niacin extended-release) and simvastatin. Simcor is approved for use along with diet to lower levels of total cholesterol, LDL cholesterol, and triglycerides, and to raise HDL cholesterol in patients with complex lipid disease.

AbilifyTablets and Oral Solution (aripiprazole),, are now approved for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, with or without psychotic features in pediatric patients 10 to 17 years old. Bristol-Myers Squibb and Tokyo-based Otsuka Pharmaceutical partnered in their development.

The FDA added descriptions of two new regimens for Merck's Janumet (sitagliptin/metformin HCl). Information has been added for Janumet ( that describes using the DPP-4 inhibitor/biguanide combination drug as initial therapy in diabetes patients who are inadequately controlled with diet and exercise alone, and as an add-on therapy to a sulfonylurea when the combination of a sulfonylurea and metformin does not provide adequate glycemic control.

Nexium (esomeprazole magnesium) has been approved for short-term use in children ages one to 11 years for the treatment of gastroesophageal reflux disease (GERD). The approval covers AstraZeneca's Nexium,, in two forms, a delayed-release capsule and liquid formulation. Nexium is approved in 10 or 20 mg daily for children one to 11 years old and in doses of 20mg or 40mg for pediatric patients 12 to 17 years of age.

Luvox CR (fluvoximine maleate), which is distributed by Jazz Pharmaceuticals ( has been approved for the treatment of social anxiety disorder and obsessive compulsive disorder.

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