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.
Read more: Zuplenz (ondansetron) FDA Approval History
Infergen (interferon alfacon-1)
Labeling Revision Approved: July 2, 2010
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
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
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%
New Dosage Form Approved: July 23, 2010
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
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
Read more: 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.
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
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
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
New Indication Approved: December 22, 2015
- Merz North America Announces FDA Approval of Xeomin (incobotulinumtoxinA) for Treatment of Adult Upper Limb Spasticity