Pharmacy & Therapeutics - May 2008 - (Page 264) NEW DRUGS NEW DRUGS Rotarix Oral Vaccine For Rotavirus Gastroenteritis Avant Immunotherapeutics has announced that its partner, GlaxoSmithKline, has received approval from the Food and Drug Administration (FDA) to market Rotarix vaccine to prevent rotavirus gastroenteritis in infants. The Centers for Disease Control and Prevention (CDC) currently recommends that children complete the rotavirus immunization series by six months of age. Rotavirus infects virtually every child in the U.S. by five years of age and is the leading cause of severe gastroenteritis in infants and young children worldwide. In the U.S., the rotavirus season typically begins in the southwest during November and December and spreads to the northeast by April and May. Avant licensed the technology to GlaxoSmithKline in 1997. (Sources: Avant, April 4, 2008, www. avantimmune.com; www.medicalnewstoday.com.) DRUG NEWS creased risk for serious adverse effects, including serious infections that can lead to hospitalization or death. Because certolizumab affects the immune system, it can lower the body’s ability to fight infections and may cause malignancies. In cases of serious infections, the drug should be discontinued immediately. (Source: FDA, April 23, 2008.) tan (Imitrex) and 500 mg of naproxen sodium. Available in 25-mg, 50-mg and 100-mg strengths, it is the first migraine product that combines a triptan and an anti-inflammatory pain reliever in a single tablet. In clinical trials, the tablet provided more pain relief at two hours compared with sumatriptan 85 mg or naproxen sodium 500 mg alone. Fewer patients receiving Treximet needed a rescue medication to treat their migraine attack than those taking sumatriptan 85 mg. (Source: GlaxoSmithKline/Pozen, April 15, 2008.) Regadenoson (Lexiscan) For Cardiac Stress Tests CV Therapeutics, Inc., and Astellas have announced the approval of regadenoson injection (Lexiscan) for use in a test that detects coronary artery disease in patients who cannot undergo an exercise stress test. This pharmacological stress agent is used in radionuclide myocardial perfusion imaging (MPI). It is delivered as a rapid bolus in about 10 seconds without regard to body weight. Cardiac stress tests identify areas of poor blood flow in the heart. Lexiscan is not indicated for patients with second-degree or third-degree atrioventricular block or sinus node dysfunction who do not have a functioning artificial pacemaker. (Sources: CV Therapeutics/Astellas, April 10, 2008; www.Lexiscan.com.) Aplenzin for Depression In Adults Biovail Corporation has received the FDA’s approval for its New Drug Application (NDA) for Aplenzin (BVF-033), a once-daily formulation of bupropion hydrobromide for the treatment of depression in adults. This alcohol-resistant formulation of a new bupropion salt has been approved as 174-mg, 348-mg, and 522-mg extended-release tablets. (Source: Biovail, April 23, 2008.) Generic Ocuflox (Ofloxacin) For Eye Infections Akorn’s Abbreviated New Drug Application (ANDA) for Ofloxacin Ophthalmic Solution USP, 0.3%, has been approved. This sterile anti-infective agent is used to treat ocular infections caused by bacteria in conjunctivitis and corneal ulcers. This product is the generic version of Allergan’s Ocuflox. The launch is scheduled for the third quarter of 2008. (Source: Akorn, April 17, 2008.) Certolizumab (Cimzia) For Crohn's Disease Certolizumab pegol (Cimzia, UCB) has been approved for adults with moderate-to-severe Crohn’s disease who have not responded to conventional therapies. This product was approved with a Medication Guide. This debilitating inflammatory bowel disease affects more than one million men and women worldwide. Certolizumab reduces signs and symptoms of the disease, but patients must be closely monitored. Patients receive an injection every two weeks for the first three injections. After the benefit has been established, the medication is given once every four weeks. Patients receiving this drug are at in- NEW INDICATIONS Abatacept (Orencia) For Juvenile Rheumatoid Arthritis Bristol-Myers Squibb has received approval to market abatacept (Orencia) to reduce signs and symptoms in pediatric patients six years of age and older with moderately to severely active juvenile rheumatoid arthritis (JRA), also called juvenile idiopathic arthritis. It may be used as monotherapy or concomitantly with methotrexate (MTX). The approval of this indication was based on the AWAKEN trial (Abatacept Withdrawal study to Assess efficacy and Sumatriptan/Naproxen (Treximet) for Migraine Treximet (GlaxoSmithKline/Pozen), a combination tablet, has been approved for the acute treatment of migraine with or without aura in adults. Treximet contains 85 mg of sumatrip- 264 P&T® • May 2008 • Vol. 33 No. 5 http://www.avantimmune.com http://www.avantimmune.com http://www.medicalnewstoday.com http://www.medicalnewstoday.com http://www.Lexiscan.com
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