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: Facial Wrinkles
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, Graft-versus-host disease
Jakafi (ruxolitinib) is a Janus kinase (JAK) inhibitor used for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.
Erwinaze (asparaginase Erwinia chrysanthemi) Injection
Date of Approval: November 18, 2011
Company: Jazz Pharmaceuticals
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
Marketing Status: Discontinued
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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