New products: Rx, OTC, etc., for DRUG TOPICS Aug. 9, '04
Pharmion Corp., Boulder, Colo., (720) 564-9100, is launching Vidaza (azacitidine for injectable suspension) following an earlier approval. Vidaza is indicated for the treatment of myelodysplastic syndromes. Azacitidine is a cytostatic agent that has been used for treating leukemias.
Newly approved Xifaxan (rifaximin) tablets, in 200-mg strength, began shipping from Salix Pharmaceuticals, Raleigh, N.C., (919) 862-1000. The oral antibiotic treats traveler's diarrhea caused by E. coli.
Rheumatrex (methotrexate sodium tablets), a once-weekly disease-modifying antirheumatic drug, is being relaunched by Stada Pharmaceuticals, Cranbury, N.J., (800) 542-6682, following its 2002 acquisition from Wyeth and FDA marketing approval late last year. Along with the drug, Stada is providing a comprehensive patient compliance and education program. The drug is recommended for management of moderate and severe active rheumatoid arthritis in adults and active polyarticular juvenile arthritis in children.
Pan American Laboratories (Pamlab, L.L.C.), Mandeville, La., (985) 893-4097, is launching an enhanced formulation of FOLTX. Now containing 2 mg of cyanocobalamin (in addition to 2.5 mg folacin and 25 mg pyridoxine per tablet), the new formulation is expected to better meet the nutritional requirements of patients with vitamin B12 deficiency and those diagnosed with hyperhomocysteinemia. FOLTX is considered a prescription-only medical food and is to be used only under the direction and supervision of a physician.
Prevacid (lansoprazole) is now FDA-approved for short-term treatment of symptomatic gastroesophageal reflux disease and erosive esophagitis in children ages 12 to 17 years. The manufacturer is TAP Pharmaceutical Products, Lake Forest, Ill., (800) 621-1020.
Ortho-McNeil Pharmaceutical, Raritan, N.J., (800) 682-6532, has been granted a new indication for Levaquin (levofloxacin) tablets and injection. The fluoroquinolone antibiotic is now cleared to treat multidrug-resistant strains of Streptococcus pneumoniae in community-acquired pneumonia.
A new indication for Aldara (imiquimod) Cream 5% has been granted to 3M Pharmaceuticals, St. Paul, Minn., (651) 737-6501. Currently approved for treating actinic keratosis and external genital warts, Aldara is newly approved for the treatment of superficial basal cell carcinoma.
TAP Pharmaceutical Products has received approval of new dosing options for Prevacid (lansoprazole) SoluTab delayed-release orally disintegrating tablets. The proton pump inhibitor can now be administered via oral syringe or nasogastric tube after being dissolved in water. As an orally disintegrating formulation, it can be taken with or without water.
Hectorol (doxercalciferol), indicated in the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis, has been approved in a 0.5-mcg capsule strength. The manufacturer is Bone Care International, Middletown, Wis., (608) 662-7800.
Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000, has approval to include new data and dosing in its package insert for Reyataz (atazanavir sulfate), based on a recent study. Labeling for Reyataz now indicates that the drug can be combined with low-dose ritonavir in treatment-experienced HIV-infected patients.
American Pharmaceutical Partners, Schaumberg, Ill., (847) 969-2700, is bringing dimenhydrinate injection back onto the market. Shortage of the drug was followed by its discontinuance for two years. The antiemetic, a generic equivalent to Pfizer's Dramamine, is indicated for the prevention and treatment of the nausea, vomiting, or vertigo of motion sickness.
APP also holds two additional approvals. A free-flowing tobramycin powder for injection, said to be consistent with the innovator product Nebcin (previously discontinued by Eli Lilly), is indicated for the treatment of septicemia, lower respiratory tract infections, serious central nervous system infections, and intra-abdominal infections; skin, bone, and skin structure infections; and complicated and recurrent urinary tract infections. Piperacillin for injection, USP, available in a 40-gm vial, is a generic equivalent of Wyeth's Pipracil. The antibiotic is used to treat serious infections caused by designated susceptible microorganisms, such as pseudomonas, and is active against a variety of gram-positive and gram-negative aerobic and anaerobic bacteria.
In time for the fall cough/cold season, new Mucinex DM will be available from Adams Laboratories, Fort Worth, (817) 354-3858. The product combines 600 mg of extended-release guaifenesin for chest congestion and 30 mg of dextromethorphan HBr as a cough suppressant. According to the company, this is the first OTC product in this formulation ... Adams is also redesigning the package graphics for its Mucinex 600-mg extended-release tablets, making the product and its benefits more readily identifiable.
Aphios Corp., Woburn, Mass., (781) 932-6933, is introducing SuperCool St. John, an advanced formulation of an enhanced hyperforin fraction of St. John's wort. The product is formulated to relieve mild to moderate mood swings and promote feelings of well-being.
ScienceBased Health, Carson City, Nev., (888) 433-4726, has unveiled HydroEye Plus Lutein, an oral formulation to relieve the discomfort of dry eyes and help maintain macular health.
Nancy Jillard. New Product Newswire. Drug Topics Aug. 9, 2004;148:51.