Medication Monitor

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Generic Name (Trade Name—Company)
  • July 8, 2011


    Prevention of tetanus, diphtheria, and pertussis in patients 65 years of age and older

    FDA announced that Boostrix, given as a single-dose booster shot, has been approved for this additional indication. This is the only vaccine approved to prevent all three diseases in older patients. Boostrix was previously approved for patients 10 through 64 years of age. Data from approximately 1,300 patients showed that antibody responses to pertussis, tetanus, and diphtheria in patients ages 65 and older were comparable with those observed with previous vaccines. Headache, fatigue, and pain at the injection site were the most common adverse events observed in this patient population.

  • June 30, 2011


    Management of breakthrough pain in adults with cancer 

    This fentanyl nasal spray is indicated for adults 18 years of age and older who are already receiving opioid therapy but are tolerate to this therapy for their underlying persistent cancer pain. The nasal spray delivers fentanyl as a fine mist to the mucus membrane, with the drug rapidily being absorbed into the bloodstream. Once a dose is taken, patients must wait at least 2 hours before taking another dose. The spray will be available in the second half of this year through a Risk Evaluation and Mitigation Strategy (REMS) program intended to minimize the risk of misuse, abuse, addiction, overdose, and serious complications as a result of medication errors. Under the REMS program, pharmacies, distributors, and health providers who prescribe to outpatients are required to enroll in the program to dispense, distribute, and prescribe fentanyl spray. 

  • June 24, 2011


    Treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy 

    According to a press release by Celgene, FDA approval of romidepsin was based on data from two studies demonstrating an improved response rate in patients with PTCL. Improvements in hard clinical outcomes, such as improvement in overall survival, have not been demonstrated. Romidespin was previously approved for treatment of cutaneous T-cell lymphoma in patients who have received at least one prior systemic therapy.


  • June 22, 2011


    Treatment of moderate to severe pain associated with chronic anal fissures 

    Rectiv is the only FDA-approved prescription product for patients with this condition. Accoding to a company press release, the ointment will be available in a 0.4% strength in the first quarter of 2012.


  • June 20, 2011


    Treatment of susceptible bacterial infections

    FDA announced that the first generic versions of levofloxacin tablets, oral solution, and injectable solution have been approved. Twelve manufacturers have approved applications for levofloxacin: Akorn, Aurobindo Pharma, Dr. Reddy’s Laboratories, Glenmark Generics, Hi-Tech Pharmacal, Lupin, Mylan, Sagent Strides, Sandoz, Teva, Torrent, and Wockhardt. The drug is indicated for the treatment of susceptible bacterial infections including acute sinusitis, acute exacerbations of chronic bronchitis, nosocomial or community-acquired pneumonia, urinary tract infections, acute pyelonephritis, chronic bacterial prostatitis, and skin and skin structure infections. Levofloxacin is also indicated to reduce incidence or progression of disease following exposure to inhalational anthrax.