New Drug Approvals Archive - July 2010

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.

• FDA Approves Strativa Pharmaceuticals' Zuplenz (ondansetron) Oral Soluble Film
• Zuplenz (ondansetron) FDA Approval History

Infergen (interferon alfacon-1)

Labeling Revision Approved: July 2, 2010

• Three Rivers Pharmaceuticals Announces FDA Approval Of Expanded Labeling of Infergen

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.

• Kamada Wins FDA Approval for Glassia - a New Liquid, Ready-to-Use Treatment for Alpha-1 Antitrypsin Deficiency
• Glassia (alpha1-proteinase inhibitor (human)) FDA Approval History

Daytrana (methylphenidate)

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

• FDA Approves Daytrana (methylphenidate transdermal system) CII for the Treatment of ADHD in Adolescents
• Daytrana (methylphenidate) FDA Approval History

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.

• Stiefel, a GSK company, Receives FDA Approval of Veltin (clindamycin phosphate and tretinoin) Gel 1.2%/0.025%
• Veltin (clindamycin and tretinoin) FDA Approval History

Aricept (donepezil)

New Dosage Form Approved: July 23, 2010

• Eisai Inc. and Pfizer Inc Announce U.S. FDA Approval for New Higher-Dose Aricept (donepezil HCl) 23 mg Tablet for the Treatment of Moderate-to-Severe Alzheimer's Disease

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.

• FDA Approves Tribenzor, A New Three-In-One Combination Product for the Treatment of High Blood Pressure
• Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) FDA Approval History

Lastacaft (alcaftadine) Ophthalmic Solution

Date of Approval: July 28, 2010
Company: Allergan, Inc.
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.

• FDA Approves Lastacaft (alcaftadine ophthalmic solution) for Prevention of Itching Associated with Allergic Conjunctivitis
• Lastacaft (alcaftadine) FDA Approval History

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.

• FDA Approves Cuvposa for Chronic Drooling in Children
• Cuvposa (glycopyrrolate) FDA Approval History

Simcor (niacin ER and simvastatin)

New Dosage Form Approved: July 28, 2010

• Abbott's Simcor (niacin extended-release/simvastatin) Receives FDA Approval for New Dosage Strengths
• Simcor (niacin ER and simvastatin) FDA Approval History

Xeomin (incobotulinumtoxinA) Injection

Date of Approval: July 30, 2010
Company: Merz Pharmaceuticals, LLC
Treatment for: Cervical Dystonia, Blepharospasm, Glabellar Lines, Upper Limb Spasticity, Excessive Salivation

Xeomin (incobotulinumtoxinA) is a botulinum toxin type A for the treatment of cervical dystonia, blepharospasm, glabellar lines, upper limb spasticity, and excessive drooling.

• FDA Approves Merz Pharmaceuticals' Xeomin (incobotulinumtoxinA) for the Treatment of Cervical Dystonia and Blepharospasm
• Xeomin (incobotulinumtoxinA) FDA Approval History

Xeomin (incobotulinumtoxinA)

New Indication Approved: July 20, 2011

• Merz Aesthetics Announces FDA Approval Of Xeomin (incobotulinumtoxinA) For The Temporary Improvement In The Appearance Of Moderate To Severe Glabellar Lines In Adult Patients
• Xeomin (incobotulinumtoxinA) FDA Approval History

Xeomin (incobotulinumtoxinA)

New Indication Approved: December 22, 2015

• Merz North America Announces FDA Approval of Xeomin (incobotulinumtoxinA) for Treatment of Adult Upper Limb Spasticity
• Xeomin (incobotulinumtoxinA) FDA Approval History

Xeomin (incobotulinumtoxinA)

New Indication Approved: July 3, 2018

• FDA Approves Xeomin (incobotulinumtoxinA) for Adult Patients with Sialorrhea (Excessive Drooling)
• Xeomin (incobotulinumtoxinA) FDA Approval History