New Drug Approvals Archive - January 2009
See also: New Indications and Dosage Forms for January 2009
January 2009
AllerNaze (triamcinolone acetonide) Nasal Spray - formerly AllerNase
Date of Approval: January 7, 2009
Company: Collegium Pharmaceutical, Inc.
Treatment for: Allergic Rhinitis
Marketing Status: Discontinued
AllerNaze, formerly Tri-Nasal (triamcinolone acetonide, USP) is a reformulated aqueous intranasal steroid nasal spray indicated for the once daily treatment of nasal symptoms associated with both seasonal and perennial allergic rhinitis in adults and children twelve years of age and older.
Savella (milnacipran)
Date of Approval: January 14, 2009
Company: Allergan, Inc.
Treatment for: Fibromyalgia
Savella (milnacipran) is a selective serotonin and norepinephrine reuptake inhibitor indicated for the management of fibromyalgia.
RiaSTAP (Fibrinogen Concentrate (Human))
Date of Approval: January 16, 2009
Company: CSL Behring
Treatment for: Congenital Fibrinogen Deficiency
RiaSTAP (Fibrinogen Concentrate (Human)) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. RiaSTAP is not indicated for dysfibrinogenemia.
Gelnique (oxybutynin hydrochloride) Topical Gel - formerly OTG
Date of Approval: January 27, 2009
Company: Watson Pharmaceuticals, Inc.
Treatment for: Overactive Bladder
Gelnique (oxybutynin chloride) Gel is a transdermal antispasmodic which is applied to the skin once daily for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency.
Dexilant (dexlansoprazole) Delayed Release Capsules - formerly Kapidex
Date of Approval: January 30, 2009
Company: Takeda Pharmaceutical Company Limited
Treatment for: Erosive Esophagitis, GERD
Dexilant (dexlansoprazole) is a proton pump inhibitor with a novel delivery system approved for the treatment of erosive esophagitis and heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD).
Vectical (calcitriol) Ointment
Date of Approval: January 23, 2009
Company: Galderma Laboratories, L.P.
Treatment for: Psoriasis
Vectical Ointment is a Vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older.
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