Medication Monitor



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

    Uses:

    Treatment of acetaminophen overdose to minimize hepatic injury

    Cumberland announced that it has a new formulation of injection that does not contain ethylene diamine tetraacetic acid or any other stabilization and chelating agents and is preservative free. This new formulation will also have an extended shelf life of 30 months compared with 24 months for the original formulation.

  • February 1, 2011

    Uses:

    Maintenance treatment of advanced follicular lymphoma in patients who responded to initial treatment with this agent plus chemotherapy (induction treatment)

    Approval was based on data from the PRIMA (Primary Rituxan and Maintenance) study (n = 1,217), which showed that continuing rituximab therapy every 2 months for 2 years in patients who responded to initial treatment with rituximab plus chemotherapy nearly doubled progression-free survival compared with patients who stopped therapy (hazard ratio 0.54 [95% CI 0.42–0.70], P = 0.0001). Rituximab is also indicated for treatment of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia and, in combination with methotrexate, to reduce structural damage in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.

  • 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 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.

  • January 1, 2011

    The vaccine is now approved by FDA for prevention of anal cancer caused by HPV types 16 and 18 and prevention of AIN grades 1–3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16, and 18 in males and females 9 to 26 years of age. The vaccine was previously approved for prevention of cervical, vaginal, and vulvar cancers in females. The product was also licensed for prevention of genital warts in females and males.

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