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New Drug Approvals Archive - February 2007

February 2007

Amrix (cyclobenzaprine) Extended-Release Capsules

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.

Read more: Amrix (cyclobenzaprine) FDA Approval History

Alli (orlistat) 60 mg Capsules

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.

Read more: Alli (orlistat) FDA Approval History

Vyvanse (lisdexamfetamine dimesylate) Capsules - formerly NRP104

Date of Approval: February 23, 2007
Company: Shire plc
Treatment for: Attention Deficit Disorder

Vyvanse (lisdexamfetamine dimesylate) is an amphetamine derivative prodrug administered once-daily for the treatment of attention deficit hyperactivity disorder (ADHD) and binge-eating disorder.

Read more: Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

Humira (adalimumab)

New Indication Approved: February 27, 2007

Vyvanse (lisdexamfetamine dimesylate)

New Indication Approved: January 30, 2015

Read more: Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

New Drug Approvals Archive