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Latest New Drug Approvals
ATryn (Antithrombin (Recombinant)) Date of Approval: February 6, 2009 Company: GTC Biotherapeutics, Inc. Treatment for: Antithrombin III Deficiency ATryn (Antithrombin (Recombinant)) is a recombinant form of human antithrombin for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.
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.
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).
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.
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.
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.
AllerNaze (triamcinolone acetonide) Nasal Spray 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.
Epiduo (adapalene and benzoyl peroxide) Gel Date of Approval: December 8, 2008 Company: Galderma Laboratories, L.P. Treatment for: Acne Epiduo (adapalene and benzoyl peroxide) Gel is a once-daily, topical acne treatment that combines the well-tolerated retinoid adapalene, and benzoyl peroxide, a well-known antimicrobial.
Nexterone (amiodarone HCl) Injection Date of Approval: December 24, 2008 Company: Prism Pharmaceuticals Treatment for: Ventricular Fibrillation, Ventricular Tachycardia Nexterone (amiodarone HCl) Injection is a cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone Intravenous. Nexterone is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.
Ryzolt (tramadol) Extended Release Tablets Date of Approval: December 30, 2008 Company: Labopharm Inc. Treatment for: Pain Ryzolt (tramadol HCl extended release tablets) is a once-daily analgesic indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
Latisse (bimatoprost) Ophthalmic Solution Date of Approval: December 24, 2008 Company: Allergan, Inc. Treatment for: Hypotrichosis of Eyelashes Latisse (bimatoprost ophthalmic) is a prostamide indicated for the treatment of hypotrichosis (or reduced amount of hair) of the eyelashes. Growth of the eyelashes is a well documented side effect of bimatoprost which is currently approved as Lumigan for the treatment of glaucoma.
Degarelix for Injection Date of Approval: December 24, 2008 Company: Ferring Pharmaceuticals, USA Treatment for: Prostate Cancer Degarelix is an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for patients with advanced prostate cancer. Potential trade names for degarelix are still under review with the FDA.
Vasovist (gadofosveset trisodium) - formerly MS-325 Date of Approval: December 22, 2008 Company: EPIX Pharmaceuticals, Inc. Treatment for: Diagnostic Vasovist (gadofosveset trisodium) is a blood pool magnetic resonance angiography (MRA) agent used to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.
Zolpimist (zolpidem tartrate) Oral Spray Date of Approval: December 19, 2008 Company: NovaDel Pharma, Inc. Treatment for: Insomnia Zolpimist is an oral spray formulation of zolpidem, the drug contained in Ambien. Zolpimist is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Oral Fludarabine (fludarabine phosphate) Tablets Date of Approval: December 18, 2008 Company: Antisoma plc Treatment for: Chronic Lymphocytic Leukemia Oral fludarabine (fludarabine phosphate) is an oral nucleoside analogue approved as a single agent for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL).
Mozobil (plerixafor) Date of Approval: December 15, 2008 Company: Genzyme Corporation Treatment for: Bone Marrow Transplantation Mozobil (plerixafor) is a small molecule CXCR4 chemokine receptor antagonist used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.
Trilipix (fenofibric acid) Delayed-Release Capsules Date of Approval: December 15, 2008 Company: Abbott Treatment for: Hypertriglyceridemia, Hyperlipidemia Trilipix (fenofibric acid) is a peroxisome proliferator receptor alpha (PPARα) activator indicated for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. Trilipix is the first and only fibrate to be approved for use in combination with a statin.
Lusedra (fospropofol disodium) Injection - formerly Aquavan Date of Approval: December 12, 2008 Company: Eisai Corporation of North America Treatment for: Sedation Lusedra (fospropofol disodium) is an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.
SCE-A (Synthetic Conjugated Estrogens-A) Vaginal Cream - formerly Bijuva Date of Approval: November 28, 2008 Company: Duramed Pharmaceuticals, Inc. Treatment for: Postmenopausal Symptoms SCE-A (synthetic conjugated estrogens, A) Vaginal Cream is a plant-derived local estrogen product indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, both of which are symptoms of vulvar and vaginal atrophy due to menopause.
Tapentadol Immediate Release Tablets Date of Approval: November 20, 2008 Company: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Treatment for: Pain Tapentadol is a centrally acting oral analgesic indicated for the relief of moderate to severe acute pain.
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