Medication Monitor

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Generic Name (Trade Name—Company)
  • 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.

  • January 1, 2011


    Prevention of skeletal-related events in patients with bone metastases from solid tumors

    Data from three randomized, double-blind trials comparing denosumab 120 mg with zoledronic acid 4 mg (Zometa—Novartis), both given once every 4 weeks, showed that denosumab was superior to zoledronic acid in preventing skeletal-related events in patients with breast or prostate cancer and bone metastasis and was noninferior to zoledronic acid in preventing these events in patients with multiple myeloma or other solid tumors. The FDA-recommended dose is 120 mg administered as a subcutaneous injection every 4 weeks. It is important to distinguish the dosing and indication differences between Prolia and Xgeva, both of which contain denosumab. Prolia is dosed as a 60-mg subcutaneous injection once every 6 months and is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

  • January 1, 2011


    Treatment of type 2 diabetes as an adjunct to diet and exercise as monotherapy or in combination with other oral antidiabetic agents

    The exact mechanism by which bromocriptine improves glycemic control is unknown; it may normalize aberrant hypothalamic neurotransmitter activities that induce, potentiate, and maintain the insulin-resistant, glucose-intolerant state. Data from four double-blind, placebo-controlled trials (one monotherapy and three add-on trials) involving more than 3,700 patients with type 2 diabetes showed that bromocriptine produced clinically significant improvements in glycosylated hemoglobin (A1C) (difference from placebo [range –0.4% to –0.6%]) and postprandial glucose, and more patients given bromocriptine reached an A1C goal of 7% or less compared with placebo. The recommended dose is 1.6–4.8 mg once daily. The tablets are currently available in pharmacies in a 0.8-mg strength.

  • July 7, 2002


    Management of seizures and a variety of pain conditions

    Lupin Pharmaceuticals announced that it has received FDA approval to market its generic version of Pfizer’s Lyrica capsules. The pregabalin capsules are AB rated to Pfizer's product and will be available in 25-, 50-, 75-, 100-, 150-, 200-, 225-, and 300-mg strengths.

    Pregabalin is indicated for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for adult patients with partial onset seizures, neuropathic pain associated with spinal cord injury, and fibromyalgia.