New Drug Approvals Archive

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February 2007

February 1

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.

Amrix (cyclobenzaprine) FDA Approval History

February 7

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.

Alli (orlistat) FDA Approval History

February 26

Cymbalta (duloxetine)

New Indication Approved: February 23, 2007

Cymbalta (duloxetine) FDA Approval History

February 23

Vyvanse (lisdexamfetamine dimesylate) Capsules - formerly NRP104

Date of Approval: February 23, 2007
Company: Shire plc/New River Pharmaceuticals
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). Vyvanse was developed to lower abuse potential by remaining therapeutically inactive until metabolized in the body.

Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

February 27

Humira (adalimumab)

New Indication Approved: February 27, 2007

January 3

Vyvanse (lisdexamfetamine dimesylate)

New Dosage Form Approved: December 10, 2007

Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

April 23

Vyvanse (lisdexamfetamine dimesylate)

Patient Population Altered: April 23, 2008

Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

June 1

Vyvanse (lisdexamfetamine dimesylate)

Labeling Revision Approved: May 22, 2009

Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

November 15

Vyvanse (lisdexamfetamine dimesylate)

Patient Population Altered: November 10, 2010

Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

February 7

Vyvanse (lisdexamfetamine dimesylate)

New Indication Approved: January 31, 2012

Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

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