New product newswire: January 9, 2006

January 9, 2006

Avandaryl Tablets (rosiglitazone maleate and glimepiride), fromGlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100, havereceived FDA approval. The drug is indicated as an adjunct to dietand exercise to improve glycemic control in Type 2 diabetespatients already treated with a combination of rosiglitazone andsulfonylurea, for patients not adequately controlled on asulfonylurea alone, or for patients who have responded initially torosiglitazone alone but require additional glycemic control.

RX

NEW DRUGS

Avandaryl Tablets (rosiglitazone maleate and glimepiride), from GlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100, have received FDA approval. The drug is indicated as an adjunct to diet and exercise to improve glycemic control in Type 2 diabetes patients already treated with a combination of rosiglitazone and sulfonylurea, for patients not adequately controlled on a sulfonylurea alone, or for patients who have responded initially to rosiglitazone alone but require additional glycemic control.

NEW INDICATIONS

A sixth indication has been approved for the fluoroquinolone antibiotic Avelox (moxifloxacin HCl), developed by Bayer and marketed in the United States by Schering-Plough, Kenilworth, N.J., (908) 298-4000. Avelox, available in tablet and intravenous formulations, can now be used to treat complicated intra-abdominal infections in adults. Such infections can be caused by trauma, disease, appendicitis, or abdominal surgery. The once-daily 400-mg tablets provide an easy transition from IV to oral therapy as patients leave the hospital.

The serotonin-norepinephrine reuptake inhibitor Effexor-XR (venlafaxine HCl) has received a new indication for the treatment of panic disorder in adults. A product of Wyeth Pharmaceuticals, Philadelphia, (800) 934-5556, the drug was already approved for the treatment of major depressive disorder. Regular blood pressure monitoring is recommended, as treatment with venlafaxine is associated with increases in hypertension in some patients. It was previously approved for generalized anxiety diorder and social anxiety disorder.

Jazz Pharmaceuticals' Xyrem (sodium oxybate) Oral Solution has received marketing approval for use in treating excessive daytime sleepiness in patients with narcolepsy. The product is marketed through its subsidiary Orphan Medical, Minnetonka, Minn., (888) 8-ORPHAN. The Schedule III drug was approved originally for treating cataplexy in patients with narcolepsy. Jazz is based in Palo Alto, Calif., at (650) 496-3777.

NEW FORMULATIONS

A higher-strength, non-calcium phosphate binder has been FDA-approved to better achieve target phosphate levels in adult patients who have hyperphosphatemia along with end-stage renal disease. The new strengths (750 mg and 1.0 gm) of Fosrenol (lanthanum carbonate) will permit patients to take as few as one chewable pill with each meal. Fosrenol is marketed by Shire USA, Wayne, Pa., (484) 595-3300.

Bayer has been granted approval for Kogenate FS (antihemophilic factor [recombinant], formulated with sucrose) with BIO-SET, which is the first integrated (needleless) reconstitution system for recombinant factor VIII. Approval of this system eliminates the risk of accidental needlestick injuries during reconstitution and offers greater safety and simplicity for hemophilia A patients. It requires fewer than half the components, eliminates the need for double-sided transfer and filter needles, and involves half the previous number of steps of the vial-to-vial reconstitution process. Kogenate FS can also now be stored at room temperature for up to three months.