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Carimune, the sterile, highly purified human plasma-derived intravenous immunoglobulin preparation from ZLB Behring, King of Prussia, Pa., (610) 878-4000, now carries new labeling.
Rx NEW LABELING Carimune, the sterile, highly purified human plasma-derived intravenous immunoglobulin preparation from ZLB Behring, King of Prussia, Pa., (610) 878-4000, now carries new labeling. It indicates that manufacturing steps used in the production of Carimune can substantially decrease the infectivity of transmissible spongiform encephalopathy, which includes Creutzfeldt-Jakob disease, the human form of mad cow disease.
NEW DOSING STRENGTHS Bradley Pharmaceuticals, Fairfield, N.J., (973) 882-1505, has added Zoderm 6.5% cream, cleanser, and gel to its line of acne therapies. The new product offers a moderate-strength moisturizing benzoyl peroxide therapy suitable for most acne patients.
Enbrel (etanercept), a rheumatoid arthritis and psoriasis drug, will be available in a 50-mg prefilled syringe; its prior dosing utilized twice-weekly 25-mg injections. It is expected that this dosing will be easier for patients with impaired joint mobility. Approval was issued to Amgen, Thousand Oaks, Calif., (888) 436-2735, in partnership with Wyeth Pharmaceuticals, Collegeville, Pa., (610) 688-4400.
NEW DELIVERY Wyeth Pharmaceuticals has FDA approval for the ReFacto Antihemophilic Factor (Recombinant) R2 Kit. According to the company, this is the first needle-less reconstitution device with a prefilled diluent syringe for hemophilia. ReFacto is indicated for the control and prevention of hemorrhagic episodes and for surgical and short-term routine prophylaxis in patients with hemophilia.
NEW MARKETING MGI Pharma, Minneapolis, (952) 346-4700, has begun marketing Kadian in the United States in 20-, 30-, 50-, 60-, and 100-mg capsules, each of which contains polymer-coated sustained-release pellets of morphine sulfate for oral administration. The drug is indicated for treatment of moderate to severe pain associated with cancer.
NEW GENERICS Teva Pharmaceuticals USA, North Wales, Pa., (888) TEVA USA, is introducing four new products. Sotalol hydrochloride tablets USP (AF), indicated in the management of atrial filbrillation, offer a generic alternative to Berlex's Betapace AF Tablets, 80, 120, and 160 mg. Mesalamine Rectal Suspension USP, bioequivalent to Solvay's Rowasa, treats ulcerative distal colitis, proctosigmoiditis, and proctitis. It is available in 4 gm/60mL single-use doses. Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg/5 mL, bioequivalent to GlaxoSmithKline's Augmentin ES-600 Powder for Oral Suspension, is indicated for pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae, H. influenzae, or M. catarrhalis. The oral antibiotic is available in 75-, 125-, and 200-mL bottles. Ribavirin capsules, in 200-mg strength, provide a generic equivalent to Schering Corp.'s Rebetol. The drug is used in combination with Intron A injection for treating chronic hepatitis C in adults with compensated liver disease who were previously untreated with alpha interferon or who have relapsed following interferon therapy.
Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-9200, has FDA approval to manufacture and market clorazepate dipotassium tablets USP, in 3.75-, 7.5-, and 15-mg strengths. This approval provides a generic alternative to Tranxene Tablets, from Ovation Pharmaceuticals, in the same strengths. The product is indicated for managing anxiety disorders or for short-term relief of anxiety symptoms. It is also used as adjunctive therapy in the management of partial seizures ... The company also has received approval for clarithromycin tablets USP, 250 and 500 mg. Approval provides a product that's bio-equivalent to Abbott Laboratories' Biaxin tablets in the same strengths. Clarithromycin is indicated for the treatment of mild to moderate infections caused by susceptible strains of designated microorganisms; for treating H. pylori infection and duodenal ulcer disease, along with amoxicillin and lansoprazole or omeprazole; and, in combination with omeprazole or ranitidine bismuth citrate, treating active duodenal ulcer associated with H. pylori.