New Drug Approvals Archive

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June 2009

June 1

Reclast (zoledronic acid)

New Dosage Regimen: June 1, 2009

Reclast (zoledronic acid) FDA Approval History

June 1

Lamictal (lamotrigine)

New Dosage Form Approved: May 29, 2009

June 1

Vyvanse (lisdexamfetamine dimesylate)

Labeling Revision Approved: May 22, 2009

Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

June 3

Axert (almotriptan)

Patient Population Altered: April 30, 2009

June 10

Evolence (dermal filler)

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

Evolence (dermal filler) FDA Approval History

June 11

BioThrax (Anthrax Vaccine Adsorbed)

Labeling Revision Approved: June 10, 2009

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.

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.

Zipsor (diclofenac potassium) FDA Approval History

June 17

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.

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.

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.

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.

Feraheme (ferumoxytol) FDA Approval History

September 25

Ozurdex (dexamethasone)

New Indication Approved: September 24, 2010

Ozurdex (dexamethasone) FDA Approval History

May 10

Ilaris (canakinumab)

New Indication Approved: May 10, 2013

Ilaris (canakinumab) FDA Approval History

September 29

Ozurdex (dexamethasone)

New Indication Approved: September 26, 2014

Ozurdex (dexamethasone) FDA Approval History

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