Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • February 1, 2011

    Uses:

    Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in children 2 to 10 years of age

    Approval was based on Phase III trial data involving 5,297 children 2 to 10 years of age proving the safety and immunogenicity of Menveo compared with the other currently U.S.-licensed ACW-135Y meningococcal conjugate vaccine. The vaccine was initially approved in 2010 for active immunization in adolescents and adults 11 to 55 years of age.

  • February 1, 2011

    Uses:

    Treatment of major depressive disorder (MDD) in adults

    Vilazodone has a unique mechanism of action because it is a selective serotonin reuptake inhibitor (SSRI) and a partial agonist at the 5HT1A receptor. Although the net result of this action on serotonergic transmission is not fully understood, experts have theorized that the partial agonist activity of vilazodone may decrease the occurrence of sexual adverse effects that are commonly associated with SSRIs. FDA approved the antidepressant based on two Phase III, 8-week, placebo-controlled trials involving 869 patients with MDD age 18 to 70 years showed that treatment with vilazodone 40 mg once daily was superior to placebo in the improvement of depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale total score. Some of the most common adverse events with vilazodone were diarrhea, nausea, vomiting, and insomnia

  • February 1, 2011

    Uses:

    Treatment of postherpetic neuralgia

    This new once-daily formulation of gabapentin is designed to swell in the gastric fluid and gradually release the active drug. A dose of 1,800 mg/d resulted in a statistically significant reduction in average daily pain scores compared with placebo and was generally well tolerated. This new gabapentin formulation is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles. The tablets will be marketed in 300-mg and 600-mg dosage strengths and will be available later this year.

  • February 1, 2011

    Uses:

    Treatment of breakthrough pain in adult patients 18 years of age or older with cancer who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medication

    A new formulation of fentanyl, sublingual immediate-release tablets, has been FDA approved in six different strengths: 100, 200, 300, 400, 600, and 800 µg; the 100-µg strength is recommended to be taken as the initial dose. Because serious adverse reactions, including death, have been reported with other immediate-release fentanyl transmucosal products, this product is available only through a Risk Evaluation and Mitigation Strategy program, which requires pharmacies, distributors, health care providers, and patients to enroll.

  • February 1, 2011

    Clonidine extended-release tablets and suspension have been approved by FDA. Both formulations are indicated to be taken once daily, either alone or in combination with other antihypertensive agents. The tablets will be marketed in two strengths—0.17 mg and 0.26 mg—and the suspension will be available in a 0.09 mg/mL formulation.

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