New Drug Approvals: February 2007

Date of Approval: February 1, 2007

Company: ECR Pharmaceuticals

Treatment for Muscle Spasm

Amrix is an extended-release formulation of the skeletal muscle relaxant cyclobenzaprine, indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

Date of Approval: February 7, 2007

Company: GlaxoSmithKline Consumer Healthcare

Treatment for Weight Loss

Alli is an over-the-counter weight-loss product containing orlistat, the same ingredient in prescription strength Xenical. Alli is indicated for weight loss in overweight adults 18 years and older when used along with a reduced-calorie, low-fat diet.

Date of Approval: August 3, 2004

Company: Eli Lilly and Company

Treatment for Depression, Anxiety

Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI). Cymbalta was first approved in August 2004 for the acute treatment of major depressive disorder and has since been approved for the management of neuropathic pain associated with diabetic peripheral neuropathy and for the acute treatment of generalized anxiety disorder.
New Indication Approved: November 28, 2007
Treatment for: Maintenance Treatment of Major Depressive Disorder
Cymbalta is now also approved for the maintenance treatment of major depressive disorder (MDD) in adults.

Date of Approval: February 23, 2007

Company: Shire plc/New River Pharmaceuticals

Treatment for Attention Deficit Hyperactivity Disorder (ADHD) in Children

Vyvanse is an amphetamine derivative prodrug administered once-daily for the treatment of Attention Deficit Hyperactivity Disorder. Vyvanse was developed to lower abuse potential by remaining therapeutically inactive until metabolized in the body.

Date of Approval: December 31, 2002

Company: Abbott

Treatment for Rheumatoid Arthritis

Humira is a recombinant human IgGl monoclonal antibody specific for human tumor necrosis factor (TNF) indicated for reducing the signs and symptoms, inducing major clinical response, slowing the progression of joint damage, and improving physical function in adult patients with moderate to severe rheumatoid arthritis.