FDA actions in brief

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A discussion of new FDA-approved indications and formulations of drugs

Key Points

New storage instructions were approved for exenatide (Byetta, Amylin/Eli Lilly). The agent can now be stored at room temperature after first use.

Lisdexamfetamine (Vyvanse, Shire/New River) was approved for the treatment of attention-deficit/hyperactivity disorder (ADHD).

Atorvastatin (Lipitor, Pfizer) was approved for reducing the risk of nonfatal heart attacks, fatal and nonfatal strokes, certain types of heart surgery, hospitalization for heart failure, and chest pain in patients with heart disease. This agent was previously approved to reduce the risk of cardiovascular events in patients without heart disease.

A patch containing diclofenac (Flector Tissuegel, Institut Biochimique SA) was approved for the treatment of acute pain due to minor strains, sprains, and contusions.

Cyclobenzaprine (Amrix, ECR) was approved in a new extendedrelease capsule formulation as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

Duloxetine (Cymbalta, Eli Lilly) was approved for the treatment of generalized anxiety disorder. Duloxetine was approved previously for the treatment of major depressive disorder and diabetic peripheral neuropathic pain.

A new tablet formulation of ramipril (Altace, King) was approved for the treatment of hypertension; reduction in risk of myocardial infarction, stroke, and death from cardiovascular causes; and treatment of stable patients who have demonstrated signs of congestive heart failure within the first few days after sustaining acute myocardial infarction.

A new 200-mg strength of extended-release morphine (Kadian, Alpharma) was approved for the management of moderate-tosevere chronic pain. This agent was previously approved in strengths of 20, 30, 50, 60, 80, and 100 mg.

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