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.

New Indication Approved: February 23, 2007

Date of Approval: February 23, 2007

Company: Shire plc/New River Pharmaceuticals

Treatment for Attention Deficit Disorder

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.

New Indication Approved: February 27, 2007