New Drug Approvals Archive - November 2011

Xarelto (rivaroxaban)

New Indication Approved: November 4, 2011

• FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm

Xarelto (rivaroxaban) FDA Approval History

Erbitux (cetuximab)

New Indication Approved: November 7, 2011

• FDA Approves Erbitux to Treat Late-stage Head and Neck Cancer

Erbitux (cetuximab) FDA Approval History

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

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

• FDA Approves Jakafi to Treat Myelofibrosis

Jakafi (ruxolitinib) FDA Approval History

Avastin (bevacizumab)

Labeling Revision Approved: November 18, 2011

• FDA Revokes Breast Cancer Indication for Avastin (bevacizumab)

Avastin (bevacizumab) FDA Approval History

Erwinaze (asparaginase Erwinia chrysanthemi) Injection - formerly Erwinase

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.

• 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

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

Eylea (aflibercept)

New Indication Approved: July 29, 2014
Treatment for: Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetic Macular Edema

• Eylea (aflibercept) Injection Receives FDA Approval for the Treatment of Diabetic Macular Edema

Eylea (aflibercept) FDA Approval History

Jakafi (ruxolitinib)

New Indication Approved: December 4, 2014
Treatment for: Myelofibrosis; Polycythemia Vera

• FDA Approves Jakafi (ruxolitinib) for Polycythemia Vera

Jakafi (ruxolitinib) FDA Approval History

Erwinaze (asparaginase Erwinia chrysanthemi)

New Dosage Regimen: December 19, 2014

• Jazz Pharmaceuticals Receives FDA Approval For Intravenous Administration Of Erwinaze

Erwinaze (asparaginase Erwinia chrysanthemi) FDA Approval History

Eylea (aflibercept)

New Indication Approved: March 25, 2015
Treatment for: Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetic Macular Edema

• FDA Approves Eylea (aflibercept) for Diabetic Retinopathy in Patients with Diabetic Macular Edema

Eylea (aflibercept) FDA Approval History