New Drug Approvals Archive - 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.

• IntelGenx Announces FDA Approval of its High Dose Anti-Depressant Forfivo XL
• Forfivo XL (bupropion hydrochloride) FDA Approval History

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.

• Merz Aesthetics Announces FDA Approval of Belotero Balance Dermal Filler for the Correction of Moderate-to-Severe Facial Wrinkles and Folds
• Belotero Balance (dermal filler) FDA Approval History

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 indicated for the treatment of:

• intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults.
• polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea.
• steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

• FDA Approves Jakafi to Treat Myelofibrosis
• Jakafi (ruxolitinib) FDA Approval History

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.

• FDA Approves Erwinaze to Treat Acute Lymphoblastic Leukemia
• Erwinaze (asparaginase Erwinia chrysanthemi) FDA Approval History

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.

• FDA Approves Eylea for Wet Age-Related Macular Degeneration
• Eylea (aflibercept) FDA Approval History

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.

• FDA Approves Intermezzo for Middle-of-the-Night Waking Followed by Difficulty Returning to Sleep
• Intermezzo (zolpidem tartrate) FDA Approval History