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New Drug Approvals Archive - June 2009

June 2009

June 1	Reclast (zoledronic acid) New Dosage Regimen: June 1, 2009 FDA Approves Reclast to Prevent Osteoporosis in Postmenopausal Women With Convenient Less Frequent Dosing Reclast (zoledronic acid) FDA Approval History
June 1	Lamictal (lamotrigine) New Dosage Form Approved: May 29, 2009 FDA Approves Lamictal XR; An Extended-Release Once-Daily, New Generation Treatment for Epilepsy
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
June 3	Axert (almotriptan) Patient Population Altered: April 30, 2009 Axert (almotriptan) Approved by the FDA for the Treatment of Migraine in Adolescents
June 10	Evolence (dermal filler) Labeling Revision Approved: June 8, 2009 Treatment for: Facial Wrinkles FDA Approves 12-Month Labeling Update for Evolence Collagen-Based Facial Filler Evolence (dermal filler) FDA Approval History
June 11	BioThrax (Anthrax Vaccine Adsorbed) Labeling Revision Approved: June 10, 2009 Emergent BioSolutions Receives FDA Approval Extending Shelf Life of BioThrax (Anthrax Vaccine Adsorbed) to 4 Years
June 11	Caldolor (ibuprofen) Intravenous Injection Date of Approval: June 11, 2009 Company: Cumberland Pharmaceuticals Treatment for: Pain, Fever Caldolor is an intravenous formulation of ibuprofen indicated for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever in adults. Cumberland Pharmaceuticals Announces FDA Approval of Caldolor Caldolor (ibuprofen) FDA Approval History
June 16	Zipsor (diclofenac potassium) Capsules Date of Approval: June 16, 2009 Company: Xanodyne Pharmaceuticals, Inc. Treatment for: Pain Zipsor is a rapid release diclofenac potassium formulation for the treatment of patients with mild to moderate acute pain. Xanodyne Receives Approval From the U.S. Food and Drug Administration for Zipsor (diclofenac potassium) Liquid Filled Capsules Zipsor (diclofenac potassium) FDA Approval History
June 17	Ilaris (canakinumab) Injection Date of Approval: June 17, 2009 Company: Novartis Pharmaceuticals Corporation Treatment for: Cryopyrin-Associated Periodic Syndrome, Juvenile Idiopathic Arthritis, Familial Cold Autoinflammatory Syndrome, Muckle Wells Snydrome, Familial Mediterranean Fever Ilaris (canakinumab) is a human anti-interleukin-1β monoclonal antibody for the treatment of Periodic Fever Syndromes (Cryopyrin-Associated Periodic Syndromes, Tumor Necrosis Factor Receptor Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency, Familial Mediterranean Fever) and active Systemic Juvenile Idiopathic Arthritis. New Biological Therapy Ilaris Approved In US To Treat Children And Adults With CAPS, A Serious Life-Long Auto-Inflammatory Disease Ilaris (canakinumab) FDA Approval History
June 17	Ozurdex (dexamethasone) Intravitreal Implant Date of Approval: June 17, 2009 Company: Allergan, Inc. Treatment for: Macular Edema, Uveitis Ozurdex (dexamethasone intravitreal implant) is a sustained-release, corticosteroid implant for the treatment of macular edema, non-infectious uveitis, and diabetic macular edema. Allergan Receives FDA Approval for Ozurdex Biodegradable, Injectable Steroid Implant with Extended Drug Release for Retinal Disease Ozurdex (dexamethasone) FDA Approval History
June 17	Cambia (diclofenac potassium) for Oral Solution - formerly PRO-513 Date of Approval: June 17, 2009 Company: Kowa Pharmaceuticals America, Inc. Treatment for: Migraine Cambia (diclofenac potassium) is a non-steroidal anti-inflammatory drug combined with potassium bicarbonate for the treatment of acute migraine with or without aura in adults. FDA Approves Cambia for Migraine Cambia (diclofenac potassium) FDA Approval History
June 30	Feraheme (ferumoxytol) Intravenous Injection Date of Approval: June 30, 2009 Company: AMAG Pharmaceuticals, Inc. Treatment for: Anemia Associated with Chronic Renal Failure Feraheme (ferumoxytol) is an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. FDA Approves Feraheme to Treat Iron Deficiency Anemia in Adult Chronic Kidney Disease Patients Feraheme (ferumoxytol) FDA Approval History
September 25	Ozurdex (dexamethasone) New Indication Approved: September 24, 2010 Allergan Receives FDA Approval for Ozurdex as Treatment Option for Non-Infectious Uveitis Affecting the Posterior Segment of the Eye Ozurdex (dexamethasone) FDA Approval History
May 10	Ilaris (canakinumab) New Indication Approved: May 10, 2013 Ilaris Approved by FDA to Treat Active Systemic Juvenile Idiopathic Arthritis Ilaris (canakinumab) FDA Approval History
September 29	Ozurdex (dexamethasone) New Indication Approved: September 26, 2014 FDA Approves Revised Indication for Ozurdex for the Treatment of Diabetic Macular Edema Ozurdex (dexamethasone) FDA Approval History
September 23	Ilaris (canakinumab) New Indication Approved: September 23, 2016 FDA Approves Expanded Indications for Ilaris (canakinumab) for Three Rare Periodic Fever Syndromes Ilaris (canakinumab) FDA Approval History

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