New Drug Approvals Archive - January 2009
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
Zingo (lidocaine hydrochloride monohydrate)
Patient Population Altered: January 8, 2009
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.
Read more: Savella (milnacipran) FDA Approval History
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
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
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).
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
Read more: Vectical (calcitriol) FDA Approval History