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New Drug Approvals Archive

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July 2010

July 2

Zuplenz (ondansetron) Oral Soluble Film

Date of Approval: July 2, 2010
Company: Strativa Pharmaceuticals
Treatment for: Prevention of Chemotherapy-Induced, Radiotherapy-Induced, and Postoperative Nausea and Vomiting

Zuplenz is an oral soluble film formulation of ondansetron for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.

Zuplenz (ondansetron) FDA Approval History

July 6

Infergen (interferon alfacon-1)

Labeling Revision Approved: July 2, 2010

July 1

Glassia (alpha1-proteinase inhibitor (human)) Injection - formerly AAT-IV

Date of Approval: July 1, 2010
Company: Kamada Ltd.
Treatment for: Alpha-1 Proteinase Inhibitor Deficiency

Glassia is an alpha1-proteinase inhibitor that is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1antitrypsin deficiency.

Glassia (alpha1-proteinase inhibitor (human)) FDA Approval History

July 7

Daytrana (methylphenidate)

Patient Population Altered: June 29, 2010
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Daytrana (methylphenidate) FDA Approval History

July 16

Veltin (clindamycin and tretinoin) Gel - formerly Velac

Date of Approval: July 16, 2010
Company: Stiefel Laboratories, Inc.
Treatment for: Acne

Veltin Gel (clindamycin phosphate and tretinoin) is a combination of an antibiotic and a retinoid indicated for the topical treatment of acne vulgaris.

Veltin (clindamycin and tretinoin) FDA Approval History

July 26

Aricept (donepezil)

New Dosage Form Approved: July 23, 2010

July 23

Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) Tablets

Date of Approval: July 23, 2010
Company: Daiichi Sankyo, Inc.
Treatment for: Hypertension

Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) is a three-in-one combination product taken once-daily for the treatment of hypertension.

Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) FDA Approval History

July 28

Lastacaft (alcaftadine) Ophthalmic Solution

Date of Approval: July 28, 2010
Company: Vistakon Pharmaceuticals LLC
Treatment for: Allergic Conjunctivitis

Lastacaft (alcaftadine ophthalmic solution) is a topical H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.

Lastacaft (alcaftadine) FDA Approval History

July 28

Cuvposa (glycopyrrolate) Oral Solution

Date of Approval: July 28, 2010
Company: Shionogi Pharma Inc.
Treatment for: Chronic Drooling in Children

Cuvposa (glycopyrrolate) oral solution is an anticholinergic for the treatment of chronic severe drooling caused by neurologic disorders in children.

Cuvposa (glycopyrrolate) FDA Approval History

July 29

Simcor (niacin ER and simvastatin)

New Dosage Form Approved: July 28, 2010

Simcor (niacin ER and simvastatin) FDA Approval History

July 30

Xeomin (incobotulinumtoxinA)

Date of Approval: July 30, 2010
Company: Merz Pharmaceuticals, LLC
Treatment for: Cervical Dystonia, Blepharospasm, Glabellar Lines

Xeomin (incobotulinumtoxinA) is a botulinum toxin type A for the treatment of adults with cervical dystonia, blepharospasm and glabellar lines.

Xeomin (incobotulinumtoxinA) FDA Approval History

July 21

Xeomin (incobotulinumtoxinA)

New Indication Approved: July 20, 2011

Xeomin (incobotulinumtoxinA) FDA Approval History

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