New Drug Approvals Archive
New Drug Approvals: 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| June 17 | Ilaris (canakinumab) Date of Approval: June 17, 2009 Company: Novartis AG Treatment for: Cryopyrin-Associated Periodic Syndrome Ilaris (canakinumab) is a human monoclonal antibody for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS). New Biological Therapy Ilaris Approved In US To Treat Children And Adults With CAPS, A Serious Life-Long Auto-Inflammatory Disease |
| June 17 | Ozurdex (dexamethasone) Intravitreal Implant Date of Approval: June 17, 2009 Company: Allergan, Inc. Treatment for: Macular Edema Ozurdex (dexamethasone intravitreal implant) is a sustained-release, potent steroid implant for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Allergan Receives FDA Approval for Ozurdex Biodegradable, Injectable Steroid Implant with Extended Drug Release for Retinal Disease |
| 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 |
| 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 |
New Drug Approvals Archive
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