New products: May 12, 2008

RX

NEW DRUG

The FDA has approved GlaxoSmithKline's ( http://www.gsk.com/) Rotarix (Rotavirus Vaccine, live, oral) for the prevention of rotavirus gastroenteritis in infants. The Centers for Disease Control & Prevention Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians recommend that infants receive routine rotavirus vaccination in order to prevent rotavirus gastroenteritis. Rotarix will be commercially available in the second half of this year.

NEW INDICATIONS

Orencia (abatacept) from Bristol-Myers Squibb ( http://www.orencia.com/) has been approved by the FDA for reducing signs and symptoms in pediatric patients six years and older with moderately to severely active polyarticular juvenile idiopathic arthritis. Orencia may be used as monotherapy or concomitantly with methotrexate, but should not be administered concomitantly with tumor necrosis factor antagonists and is not recommended for use concomitantly with biologic rheumatoid arthritis (RA) therapy, such as anakinra. Orencia was previously approved for adults who have not been helped by other RA therapies.

Eisai's Aloxi (palonosetron hydrochloride) injection, http://www.aloxi.com/, is now approved for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated. Aloxi was first approved in 2003 for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of both moderately and highly emetogenic chemotherapy. The new indication is based on one double-blind Phase III study that evaluated the efficacy of three doses of Aloxi compared with placebo for the prevention of PONV.

NEW LABEL

The FDA has approved label changes for the combination therapy of Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin, USP) for chronic hepatitis C. The new label for the Schering-Plough's ( http://www.schering-plough.com/) medications recommends weight-based dosing of Rebetol (800-1400 mg daily) based on patient body weight. The revised label also recommends a shorter, 24-week course of the combination therapy for patients with chronic hepatitis C virus (HCV) genotype 2 or 3. The label changes are based on the results of the WIN-R trial hepatitis C study conducted in more than 4,900 patients. In the United States, Pegintron is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and who are at least 18 years of age.

Novo Nordisk has received approval from the FDA for new labeling for NovoLog (insulin aspart [rDNA origin] injection) for continuous subcutaneous insulin infusion (CSII) by external insulin pump in pediatric patients between the ages of four and 18 years. NovoLog ( http://www.novolog.com/) is the first and only insulin analog approved for this use. An injection of NovoLog should be immediately followed by a meal. Because of the short duration of action of NovoLog, a longer-acting insulin should also be used in patients with Type 1 diabetes and may also be needed in patients with Type 2 diabetes. NovoLog is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog or one of its excipients.