New Drug Approvals Archive

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

Lamictal (lamotrigine)

New Dosage Form Approved: May 29, 2009

• FDA Approves Lamictal XR; An Extended-Release Once-Daily, New Generation Treatment for Epilepsy

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

Axert (almotriptan)

Patient Population Altered: April 30, 2009

• Axert (almotriptan) Approved by the FDA for the Treatment of Migraine in Adolescents

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

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

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

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

Ilaris (canakinumab)

Date of Approval: June 17, 2009
Company: Novartis AG
Treatment for: Cryopyrin-Associated Periodic Syndrome, Juvenile Idiopathic Arthritis

Ilaris (canakinumab) is a human monoclonal antibody for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS), and for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older.

• 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

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 following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) and for the treatment of non-infectious uveitis affecting the posterior segment of the eye.

• Allergan Receives FDA Approval for Ozurdex Biodegradable, Injectable Steroid Implant with Extended Drug Release for Retinal Disease

Ozurdex (dexamethasone) FDA Approval History

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

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

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

Ilaris (canakinumab)

New Indication Approved: May 10, 2013

• Ilaris Approved by FDA to Treat Active Systemic Juvenile Idiopathic Arthritis

Ilaris (canakinumab) FDA Approval History