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New Drug Approvals Archive - February 2007

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 Approved - ECR Pharmaceuticals - 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. FDA Approves alli (orlistat 60 mg capsules) Over-The-Counter Alli (orlistat) FDA Approval History
February 26	Cymbalta (duloxetine) New Indication Approved: February 23, 2007 FDA Approves Cymbalta for Treatment of Generalized Anxiety Disorder Cymbalta (duloxetine) FDA Approval History
February 23	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. Shire Receives FDA Approval of Vyvanse for ADHD Vyvanse (lisdexamfetamine dimesylate) FDA Approval History
February 27	Humira (adalimumab) New Indication Approved: February 27, 2007 Humira (Adalimumab) Receives FDA Approval For Treatment of Crohn'sDisease
January 3	Vyvanse (lisdexamfetamine dimesylate) New Dosage Form Approved: December 10, 2007 FDA Approves Additional Dosage Strengths of Shire's ADHD Treatment Vyvanse (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients Vyvanse (lisdexamfetamine dimesylate) FDA Approval History
April 23	Vyvanse (lisdexamfetamine dimesylate) Patient Population Altered: April 23, 2008 FDA Approves Vyvanse (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults Vyvanse (lisdexamfetamine dimesylate) FDA Approval History
June 1	Vyvanse (lisdexamfetamine dimesylate) Labeling Revision Approved: May 22, 2009 FDA Approves Labeling Change for Vyvanse (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD Vyvanse (lisdexamfetamine dimesylate) FDA Approval History
November 15	Vyvanse (lisdexamfetamine dimesylate) Patient Population Altered: November 10, 2010 FDA Approves Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the Treatment of ADHD in Adolescents Vyvanse (lisdexamfetamine dimesylate) FDA Approval History
February 7	Vyvanse (lisdexamfetamine dimesylate) New Indication Approved: January 31, 2012 Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) Now Approved in the US for Maintenance Treatment in Adults with ADHD Vyvanse (lisdexamfetamine dimesylate) FDA Approval History
January 30	Vyvanse (lisdexamfetamine dimesylate) New Indication Approved: January 30, 2015 FDA Expands Uses of Vyvanse to Treat Binge-Eating Disorder Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

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