New Drug Approvals Archive
New Drug Approvals: 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 |
| 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 |
| February 26 | Cymbalta (duloxetine)
New Indication Approved: February 23, 2007 FDA Approves Cymbalta for Treatment of Generalized Anxiety Disorder |
| 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. Vyvanse was developed to lower abuse potential by remaining therapeutically inactive until metabolized in the body. Shire Receives FDA Approval of Vyvanse for ADHD |
| February 27 | Humira (adalimumab)
New Indication Approved: February 27, 2007 Humira (Adalimumab) Receives FDA Approval For Treatment of Crohn's Disease |
| 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 |
| 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 |
| 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 |
New Drug Approvals Archive
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