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New Drug Approvals Archive - June 2009

See also: New Indications and Dosage Forms for June 2009

June 2009

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.

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.

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, Still's Disease, Tumor Necrosis Factor Receptor Associated Periodic Fever Syndrome, Hyperimmunoglobulin D Periodic Fever Syndrome

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 Still’s disease, including Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA).

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.

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.

Feraheme (ferumoxytol) Intravenous Injection

Date of Approval: June 30, 2009
Company: AMAG Pharmaceuticals, Inc.
Treatment for: Anemia Associated with Chronic Renal Failure, Iron Deficiency Anemia

Feraheme (ferumoxytol) is an iron replacement therapy for the treatment of iron deficiency anemia in adult patients.

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