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New Drug Approvals Archive - November 2011

See also: New Indications and Dosage Forms for November 2011

November 2011

Forfivo XL (bupropion hydrochloride) Extended Release Tablets

Date of Approval: November 10, 2011
Company: IntelGenx Corp.
Treatment for: Depression

Forfivo XL (bupropion) is a high-strength formulation of the aminoketone antidepressant bupropion (contained in Wellbutrin) indicated for the treatment of major depressive disorder.

Belotero Balance (dermal filler)

Date of Approval: November 16, 2011
Company: Merz Pharmaceuticals, LLC
Treatment for: Glabellar Lines

Belotero Balance (dermal filler) is a hyaluronic acid-based cohesive gel dermal filler for the correction of moderate to severe facial wrinkles and folds.

Jakafi (ruxolitinib) Tablets

Date of Approval: November 16, 2011
Company: Incyte Corporation
Treatment for: Myelofibrosis; Polycythemia Vera

Jakafi (ruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of patients with myelofibrosis and polycythemia vera.

Erwinaze (asparaginase Erwinia chrysanthemi) Injection

Date of Approval: November 18, 2011
Company: EUSA Pharma, Inc.
Treatment for: Acute Lymphoblastic Leukemia

Erwinaze (asparaginase Erwinia chrysanthemi) is an antineoplastic agent used to treat patients with acute lymphoblastic leukemia (ALL) who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs.

Eylea (aflibercept) Injection

Date of Approval: November 18, 2011
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetic Macular Edema

Eylea (aflibercept) is a VEGF inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

Intermezzo (zolpidem tartrate) Sublingual Tablets

Date of Approval: November 23, 2011
Company: Transcept Pharmaceuticals, Inc.
Treatment for: Insomnia

Intermezzo is a low dose, fast acting, sublingual formulation of the hypnotic agent zolpidem, indicated for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.

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