Medication Monitor

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Generic Name (Trade Name—Company)
  • June 20, 2011


    Management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate     

    Pfizer and Acura announced the approval of Oxecta, an immediate-release formulation of oxycodone tablets with specialized technology to decrease tampering associated with opioid abuse and misuse. The AVERSION technology comprises a unique composition of commonly used pharmaceutical ingredients.  


  • May 20, 2011


    Treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (NET) in patients with unresectable locally advanced or metastatic disease

    Sunitinib is also approved for the treatment of advanced renal cell carcinoma and gastrointestinal stromal tumor (GIST) after disease progression with imatinib (Gleevec—Novartis) or in those with GIST intolerant to imatinib. Data from the SUN 111 trial showed that patients with unresectable pancreatic NET treated with sunitinib had a clinically significant improvement in progression-free survival compared with placebo (10.2 mo vs. 5.4 mo). An objective response rate of 9.3% was also observed in the sunitinib group, while no objective response occurred in the placebo group. The recommended dose for pancreatic NET is 37.5 mg once daily without a scheduled off-treatment period. 


  • May 17, 2011


    Short-term management (up to 5 d) of moderate to moderately severe pain that requires analgesia at the opioid level 

    This new formulation of ketorolac is rapidly absorbed through the nasal mucosa, achieving peak blood levels as quickly as an I.M. injection of the drug. The recommended dose for patients younger than 65 years of age is one spray in each nostril (total dose 31.5 mg) every 6 to 8 hours, up to a maximum daily dose of 126 mg (four doses). For those who are at least 65 years of age, renally impaired, or who weigh less than 50 kg, the recommended dose is one spray in one nostril (total dose: 15.75 mg) every 6 to 8 hours up to a maximum daily dose of 63 mg (four doses). The spray will be marketed in a bottle containing eight sprays, with each spray containing 15.75 mg of ketorolac. The spray bottle needs to be discarded within 24 hours of taking the first dose, even if active drug remains in the container. 



  • May 10, 2011


    Active immunization against influenza virus in adults 18 to 64 years of age  

    Sanofi pasteur announced the approval of the first influenza vaccine licensed in the United States that uses a novel microinjection system for intradermal delivery. Fluzone Intradermal differs from the I.M. formulation of Fluzone in that it features an ultrafine needle that is 0.06 inches in length and the vaccine contains 9 µg of hemagglutinin per strain of influenza in a 0.1 mL dose. The Fluzone I.M. formulation is administered using a needle 1 to 1.5 inches in length and contains 15 µg of hemagglutinin per strain of influenza in a 0.5 mL dose. In a Phase III clinical trial involving 4,276 adults, Fluzone Intradermal was found to induce immunologic responses that were comparable with the I.M. formulation. Since this new formulation deposits medication near the surface of the skin, local reactions occurred frequently, including redness, swelling, induration, pain, and pruritus. Fluzone Intradermal will be available during the upcoming 2011–12 influenza season.


  • May 1, 2011


    Treatment of patients with progressive neuroendocrine tumors located in the pancreas that are unresctable, locally advanced, or metastatic

    Approval was based on data from a randomized, double-blind, multicenter trial that compared use of everolimus 10 mg once daily plus best supportive care (n = 207) versus placebo plus best supportive care (n = 203) in patients with disease progression within the previous 12 months. Treatment with everolimus resulted in a statistically significant improvement in investigator-determined progression-free survival compared with placebo (median 11.0 vs. 4.6 mo).