New Drug Approvals Archive - July 2010
See also: New Indications and Dosage Forms for July 2010
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.
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.
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.
Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) Tablets
Date of Approval: July 23, 2010
Company: Daiichi Sankyo, Inc.
Treatment for: High Blood Pressure
Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) is a three-in-one combination product taken once-daily for the treatment of hypertension.
Lastacaft (alcaftadine) Ophthalmic Solution
Date of Approval: July 28, 2010
Company: Allergan, Inc.
Treatment for: Conjunctivitis, Allergic
Lastacaft (alcaftadine ophthalmic solution) is a topical H1 histamine receptor antagonist for eye allergy itch relief.
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.
Xeomin (incobotulinumtoxinA) Injection
Date of Approval: July 30, 2010
Company: Merz Pharmaceuticals, LLC
Treatment for: Cervical Dystonia, Blepharospasm, Facial Wrinkles, 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.
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