The FDA has approved Nascobal (cyanocobalamin USP) Nasal Spray for Nastech Pharmaceutical, Bothell, Wash., (888) 514-5208. The intranasal spray is indicated for vitamin ?2 deficiency in patients with pernicious anemia, Crohn's disease, HIV/AIDS, and multiple sclerosis.
RxNEW DRUGS The FDA has approved Nascobal(cyanocobalamin USP) Nasal Spray for Nastech Pharmaceutical, Bothell, Wash., (888) 514-5208. The intranasal spray is indicated for vitamin ±2 deficiency in patients with pernicious anemia, Crohn's disease, HIV/AIDS, and multiple sclerosis.
Mayne Pharma, Paramus, N.J., (201) 225-5500, is launching a new multivitamin infusion, M.V.I.-12 (multivitamin infusion without vitamin K). It is indicated for the prevention of vitamin deficiency and thromboembolic complications in patients receiving total parenteral nutrition (TPN) infusions along with warfarin-type anticoagulant therapy. Administration of vitamin K can antagonize the action of warfarin.
NEW FORMULATIONS A new aqueous solution formulation of Eloxatin (oxaliplatin injection) has been approved by the FDA. The preservative-free formulation requires no reconstitution prior to dilution and administration. The antineoplastic agent is used in combination with infusional 5-fluorouracil and leucovorin (5-FU/LV) for adjuvant treatment of Stage III colon cancer patients who have undergone complete resection of the primary tumor. The drug is also indicated for the treatment of advanced carcinoma of the colon or rectum. The maker of the agent is Sanofi-Synthelabo, New York, N.Y., (212) 551-4000.
With the transition of the last of its CFC-containing respiratory products to CFC-free formulations, GlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100, now offers Flovent HFA (fluticasone propionate HFA) Inhalation Aerosol free of chlorofluorocarbon as a propellant.
NEW DOSAGE STRENGTHS ALZA Corp. has FDA approval for Duragesic 12 mcg/hr (fentanyl transdermal system) patch. It is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, 24-hour opioid administration for an extended period for pain that cannot be managed by nonsteroidal analgesics, opioid combination products, or immediate-release opioids. The Duragesic patch was already approved in 25-, 50-, 75-, and 100-mcg/hr strengths.
NEW PACKAGING Adoxa Pak 1/100 mg (31 tablets) and Adoxa Pak 2/100 (60 tablets), from Doak Dermatologics, Fairfield, N.J., (800) 929-9300, offer convenient oral doxycycline treatment for acne. The drug is dispensed in a blister pack for easy compliance. The tablets are otherwise available in 50-, 75-, and 100-mg strengths in bottles of 100; 100 and 500; and 50 and 250 tablets, respectively.
Hemorrhoid therapy in a new presentation is available in the Kenwood Therapeutics Anamantle HC Cream Kit. Each box of 20 individually wrapped single-use kits contains sufficient medication for 10 twice-daily treatments. The 7-oz tube of cream combines lidocaine hydrochloride 3% to alleviate discomfort and hydrocortisone acetate 0.5% to reduce swelling. The pH-balancing base fosters a healing environment. Also included in the kit is a premoistened cleansing wipe with aloe. Kenwood Therapeutics is in Fairfield, N.J., at (973) 882-2402.
CutisPharma, Beverly, Mass., (978) 867-1010, has introduced another FIRST preweighed, premeasured standardized kit for prescription compounding. FIRST - Mouthwash BLM offers a unit-of-use kit for the preparation of a mouthwash containing lidocaine HCl powder, diphenhydramine HCl powder, and a suspension similar to Maalox. The compound has been used to treat such conditions as thrush and aphthous ulcers. Pharmacists should add the powders to the suspension and shake the ingredients together. The ingredients have a shelf life of two years; the compounded formulation is stable for "at least 90 days." CutisPharma kits meet the 2002 FDA Compliance Policy Guidance for Pharmacy Compounding.