Pharmacy & Therapeutics - April 2008 - (Page 204) NEW DRUGS including lung and breast cancers. It is currently approved and marketed in Japan for treating small-cell lung cancer by Nippon Kayaku. This type of lung cancer tends to be more aggressive than the more common non–small-cell lung cancer. (Source: Celgene, March 25, 2008.) DRUG NEWS indicated for use in adults and children six years of age and older. Levocetirizine is featured in the Pharmaceutical Approval Update column on page 237. (Source: Sanofi-Aventis, February 20, 2008.) NEW INDICATIONS Pediatric Uses Esomeprazole (Nexium) For Reflux Esomeprazole magnesium (Nexium, AstraZeneca) is now approved as a delayed-release capsule and as a liquid for the short-term use in children from one year to 11 years of age for the treatment of gastroesophageal reflux disease. The dosage strengths are 10 or 20 mg daily for children from one year to 11 years of age and 20 or 40 mg for children from 12 to 17 years of age. (Source: FDA, February 28, 2008.) approved for children between the ages of four and 18 years. In a 16-week study that compared aspart with lispro (Humalog, Eli Lilly), both treatment groups had a similar proportion of young children, children, and adolescents. NovoLog is indicated for improving glycemic control in adults and children with diabetes mellitus, and it has a quicker onset and a shorter duration of action than regular human insulin. An injection of this analogue should be immediately followed by a meal. (Source: Diabetes Care, Februar y 2008; Novo Nordisk, March 18, 2008.) Fluvoxamine (Luvox CR) For SAD and OCD Jazz Pharma has announced the approval of once-daily fluvoxamine maleate extended-release capsules (Luvox CR) for adults with obsessive–compulsive disorder (OCD) and social anxiety disorder (SAD). This selective serotonin reuptake inhibitor (SSRI) incorporates Elan’s Spheroidal Oral Drug Absorption System (SODAS) technology, which is designed to minimize fluctuations during a 24-hour period. The immediate-release form has been available for years to treat OCD. Luvox CR will be available in strengths of 100 and 150 mg. (Sources: www.JazzPharmaceuticals. com, February 28, 2008; www.nimh.nih. gov.) Palonosetron (Aloxi) To Prevent Postoperative Nausea and Vomiting Helsinn Healthcare SA; its partner, Eisai; and Eisai’s U.S. subsidiary, MGI Pharma, have announced the approval of palonosetron HCl (Aloxi) injection for preventing nausea and vomiting for up to 24 hours following surgery. The recommended dose is 0.25 mg approximately 30 minutes before chemotherapy begins. Available in the U.S. since 2003, the 0.25-mg injection is the only 5-HT3 (serotonin) receptor antagonist indicated for preventing nausea and vomiting associated with initial and repeated courses of chemotherapy. (Sources: FDA; Helsinn, March 3, 2008; www.aloxi.com.) Aripiprazole (Abilify) For Bipolar Illness The FDA has approved the supplemental New Drug Application (sNDA) for aripiprazole (Abilify, Otsuka/BristolMyers Squibb) for the acute treatment of manic and mixed episodes associated with bipolar I disorder in children from 10 to 17 years of age with or without psychotic features. Aripiprazole has been approved for the acute and maintenance treatment of manic and mixed episodes associated with bipolar I disorder with or without psychotic features in adults since September 2004 and March 2005, respectively. The injectable form is indicated for adults with agitation associated with bipolar I disorder. (Source: February 29, 2008.) DRUG NEWS New Dosages For Oxymorphone (Opana) Three new dosage strengths of oxymorphone HCl extended-release tablets (Opana ER) CII have been approved: 7.5, 15, and 30 mg. An opioid analgesic, Opana ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. The approval was based on studies of Opana ER in its four original strengths (5, 10, 20, and 40 mg). Because the new dosages fall between the older strengths, the FDA did not require new safety or efficacy studies. (Source: Endo, March 4, 2008.) NEW FORMULATIONS Oral Levocetirizine (Xyzal) For Allergies and Hives The FDA has approved a New Drug Application (NDA) for levocetirizine dihydrochloride (Xyzal, UCB/SanofiAventis) 0.5 mg/mL oral solution, an antihistamine indicated for relieving symptoms of indoor and outdoor allergies and for treating chronic idiopathic urticaria. The tablets were approved in May 2007. Both formulations are now Insulin aspart (NovoLog) For Diabetic Children Novo Nordisk’s insulin aspart (rDNA origin) injection (NovoLog) has been 204 P&T® • April 2008 • Vol. 33 No. 4 http://www.jazzpharmaceuticals.com http://www.nimh.nih.gov http://www.jazzpharmaceuticals.com http://www.nimh.nih.gov http://www.aloxi.com
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