New Product Newswire: July 9, 2007

NEW DRUGS

Magnacet (oxycodone HCl/acetaminophen tablets CII), from Mallinckrodt Inc., St. Louis, (314) 654-2000, provides pain management in the form of oxycodone combined with 400 mg of acetaminophen. According to the company, this unique dosage offers physicians greater flexibility in treating patients with moderate to moderately severe pain.

NEW FORMULATIONS

The FDA has approved a new formulation of FazaClo (clozapine, USP) Orally Disintegrating Tablets. The antipsychotic drug, from Avanir Pharmaceuticals, Aliso Viejo, Calif., (949) 389-6700, is now available in bottle packaging in a 12.5-mg dosage strength.

Critical Therapeutics, Lexington, Mass., (781) 402-5700, with its promotion partner, Dey, L.P., will market twice-daily Zyflo CR (zileuton) Extended-Release Tablets. According to the company, Zyflo CR and Zyflo are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. The recommended dosing for the newly approved formulation is two 600-mg tablets twice daily for a total daily dose of 2400 mg.

NEW DOSAGE STRENGTH

NEW GENERICS

Two firms are launching alprazolam extended-release tablets, CIV. Impax Laboratories, Hayward, Calif., (510) 476-2000, and TEVA Pharmaceuticals, North Wales, Pa., (888) TEVA USA, have approval for their generic versions of Pharmacia & Upjohn's Xanax XR Tablets in strengths of 0.5-, 1-, 2-, and 3-mg. Alprazolam is indicated for the treatment of panic disorder, with or without agoraphobia ... TEVA will also market oxybutynin chloride extended-release tablets in 5- and 10-mg strengths. This generic version of Alza Corp.'s Ditropan XL is indicated for the treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency. The drug is also available in 15 mg.