New Drug Approvals Archive

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November 2011

November 4

Xarelto (rivaroxaban)

New Indication Approved: November 4, 2011

Xarelto (rivaroxaban) FDA Approval History

November 7

Erbitux (cetuximab)

New Indication Approved: November 7, 2011

Erbitux (cetuximab) FDA Approval History

November 10

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.

Forfivo XL (bupropion hydrochloride) FDA Approval History

November 16

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.

Belotero Balance (dermal filler) FDA Approval History

November 16

Jakafi (ruxolitinib) Tablets

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

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

Jakafi (ruxolitinib) FDA Approval History

November 18

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.

Erwinaze (asparaginase Erwinia chrysanthemi) FDA Approval History

November 18

Eylea (aflibercept) Injection

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

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

Eylea (aflibercept) FDA Approval History

November 23

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.

Intermezzo (zolpidem tartrate) FDA Approval History

July 29

Eylea (aflibercept)

New Indication Approved: July 29, 2014

Eylea (aflibercept) FDA Approval History

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