New Drug Approvals Archive
New Drug Approvals: January 2009
| January 7 | AllerNaze (triamcinolone acetonide) Nasal Spray - formerly AllerNase Date of Approval: January 7, 2009 Company: Collegium Pharmaceutical, Inc. Treatment for: Allergic Rhinitis 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. Collegium Pharmaceutical Announces FDA Approval of AllerNaze, a Nasal Inhaled Steroid for the Treatment of Allergic Rhinitis |
| January 9 | Zingo (lidocaine hydrochloride monohydrate)
Patient Population Altered: January 8, 2009 Anesiva Announces FDA Approval of sNDA to Expand Zingo Indication to Include Adults |
| January 14 | Savella (milnacipran) Date of Approval: January 14, 2009 Company: Forest Laboratories, Inc. and Cypress Bioscience, Inc. Treatment for: Fibromyalgia Savella (milnacipran) is a selective serotonin and norepinephrine reuptake inhibitor indicated for the management of fibromyalgia. Forest and Cypress Announce FDA Approval of Savella for the Management of Fibromyalgia |
| January 16 | RiaSTAP (Fibrinogen Concentrate (Human)) Date of Approval: January 16, 2009 Company: CSL Behring Treatment for: Congenital Fibrinogen Deficiency RiaSTAP (Fibrinogen Concentrate (Human)) is lyophilized fibrinogen for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. CSL Behring Receives FDA Approval of RiaSTAP, First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency |
| January 27 | 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. Watson's Gelnique (oxybutynin chloride) Gel 10% Approved by FDA for the Treatment of Overactive Bladder |
| January 30 | Kapidex (dexlansoprazole) Delayed Release Capsules - formerly TAK-390MR Date of Approval: January 30, 2009 Company: Takeda Pharmaceutical Company Limited Treatment for: Erosive Esophagitis, Gastroesophageal Reflux Disease Kapidex (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). FDA Approves Kapidex (dexlansoprazole) for the Treatment of GERD |
| January 23 | 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. Galderma Wins FDA Approval for Vectical Ointment, a Novel Topical Therapy for Mild-to-Moderate Plaque Psoriasis |
New Drug Approvals Archive
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