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FDA actions in brief, May 2008


Recent FDA approvals and indications (through May 2008) related to Janumet, PegIntron, Rebetol, Xyzal, Liquadd, and NovoLog.

The labeling for sitagliptin/metformin (Janumet, Merck) was updated to reflect an expanded indication. The agent is now approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.

FDA approved labeling changes for peginterferon alfa-2b (PegIntron, Schering-Plough) and ribavirin (Rebetol, Schering-Plough) as combination therapy for the treatment of chronic hepatitis C infection. The labels now recommend weight-based dosing of ribavirin (800–1,400 mg/d) and a shorter 24-week course of the combination therapy for patients with chronic hepatitis C virus genotype 2 or 3. An oral solution of levocetirizine (Xyzal, UCB) was approved for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children aged ≥6 years.

FDA approved dextroamphetamine oral solution, 5 mg/5 mL (Liquadd, Auriga) for the treatment of attention- deficit/hyperactivity disorder (ADHD).

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