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

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

• 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