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New Drug Approvals Archive - June 2009

June 2009

Evolence (dermal filler)

Labeling Revision Approved: June 8, 2009
Treatment for: Facial Wrinkles

Read more: Evolence (dermal filler) FDA Approval History

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.

Read more: 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.

Read more: Zipsor (diclofenac potassium) FDA Approval History

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.

Read more: 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, non-infectious uveitis, and diabetic macular edema.

Read more: 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.

Read more: 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.

Read more: Feraheme (ferumoxytol) FDA Approval History

New Drug Approvals Archive