Parenta Pharmaceuticals (West Columbia, SC), an Ebewe Pharma Co, recently launched Fludarabine Phosphate Injection 50 mg/2 mL (25 mg/ mL), which compares with Fludara. The product is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agentcontaining regimen. The recommended adult dose of Fludarabine Phosphate Injection is 25 mg/m2 diluted in 100 cc to 125 cc of 5% dextrose injection USP or 0.9% sodium chloride USP administered intravenously over a period of approximately 30 minutes daily for 5 consecutive days. Each 5-day course of treatment should commence every 28 days. Dosage may be decreased or delayed based on evidence of hematologic toxicity.
Abraxis Pharmaceutical Products (Schaumburg, Ill) recently received FDA approval for its abbreviated new drug application for Fosphenytoin Sodium Injection, USP, 100 mg/2 mL and 500 mg/10 mL. The product is the generic equivalent of Cerebyx (Pfizer Inc). Fosphenytoin Sodium Injection is indicated for short-term parenteral administration when other means of phenytoin administration are unavailable, inappropriate, or deemed less advantageous. The safety and effectiveness of the product in this use has not been systematically evaluated for >5 days. Fosphenytoin Sodium Injection can be used for the control of generalized convulsive status epilepticus and the prevention and treatment of seizures occurring during neurosurgery. It can also be substituted, short-term, for oral phenytoin. The product is AP-rated, preservative-free, and latex-free.
King Pharmaceuticals Inc (Bristol, Tenn) recently received FDA approval for its Thrombin-JMI (thrombin, topical, bovine, USP) Epistaxis Kit—a new intranasal spray delivery device for Thrombin-JMI for use to aid in stopping epistaxis (nosebleeds). The kit offers health care professionals in the emergency department and trauma center a convenient new alternative to achieve quick, active hemostasis during epistaxis. Thrombin-JMI is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible. About 3 in 5 Americans experience nosebleeds during their lifetime. Certain high-risk groups, such as the elderly, require rapid intervention to stem bleeding, in order to prevent further complications and potentially lifethreatening events.
bioM?rieux Inc's (Durham, NC) VIDAS D-Dimer Exclusion is indicated to exclude both pulmonary embolism (PE) and deep vein thrombosis (DVT) as a diagnosis in outpatients. VIDAS D-Dimer Exclusion is the first and only D-dimer assay to receive FDA clearance for exclusion of both conditions—with no further testing—when used in conjunction with a pretest probability assessment in low-to-moderate-probability outpatients. The clearance means that patients who present to the emergency department with suspected PE or DVT may no longer be subjected to invasive and costly imaging examinations for a negative diagnosis. The product provides easy-to-use, singledose reagents, and an automated, rapid ELISA result in less than 1 hour.
Genzyme Corp (Cambridge, Mass) and Bayer HealthCare Pharmaceuticals Inc (Wayne, NJ) recently granted regular approval for single- agent Campath for the treatment of B-cell chronic lymphocytic leukemia. Campath was initially approved in 2001 under accelerated approval regulations. The product has a boxed warning which includes information on cytopenias, infusion reactions, and infections. Campath treatment is initiated at a dose of 3 mg administered as a 2-hour intravenous (IV) infusion daily. Dose titration continues as tolerated (3 mg, 10 mg, and 30 mg) until the recommended 30-mg dose is reached. Once the full 30-mg daily treatment commences, the product is administered as a 2-hour IV infusion per session, 3 times a week for 12 weeks. Campath is supplied in single-use clear glass vials containing 30 mg of alemtuzumab in 1 mL of solution.
Bristol-Myers Squibb (Princeton, NJ) recently received FDA approval for Ixempra as monotherapy for the treatment of patients with metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine. The FDA also granted approval for Ixempra in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline, and a taxane, or whose cancer is taxane-resistant and for whom further anthracycline therapy is contraindicated. The recommended dose of Ixempra is 40 mg/m2 infused intravenously over 3 hours every 3 weeks. Dose reduction is required in certain patients with elevated AST, ALT, or bilirubin.
Ortho-McNeil Inc (Raritan, NJ) recently received FDA approval for Doribax. The product is indicated as a single agent for the treatment of intra-abdominal infections caused by susceptible strains, including Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B uniformis, and B vulgatus; and for the treatment of complicated urinary tract infections, including pyelonephritis caused by susceptible strains of E coli, including cases with concurrent bacteremia, K pneumoniae, P mirabilis, and P aeruginosa. The recommended dose of Doribax is 500 mg every 8 hours by intravenous infusion administered over 1 hour for patients ≥18 years of age.