Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • July 21, 2011

    Uses:

    Temporary improvement in the appearance of moderate to severe glabellar lines, or frown lines between the eyebrows, in adult patients 

    Merz Aesthetics announced the FDA approval of this product for the temporary improvement in the appearance of moderate to severe glabellar lines, also known as frown lines. Approval was based on data from 547 healthy adult patients that showed that injection of the drug significantly improved the appearance of glabellar lines within 30 days of the first treatment compared with placebo. IncobotulinumtoxinA is also indicated for treatment of adults with cervical dystonia or blepharospasm. The product will be available nationwide for aesthetic use in spring 2012, according to the manufacturer. 

  • July 18, 2011

    Uses:

    Management of patients with ulcerative colitis 

    Shire announced that mesalamine delayed-release tablets (Lialda) have been FDA approved for the maintenance of remission in patients with ulcerative colitis. The tablets were originally approved in 2007 for the induction of remission in patients with active, mild to moderate ulcerative colitis. Approval was based on data from a double-blind, multicenter study involving 826 adult patients in remission from ulcerative colitis. Patients were randomized to either Lialda 2.4 g/d or a comparator mesalamine delayed-release  product , given as 1.6 g/d, with both groups having similar remission rates at Month 6 (83.7% and 81.5%, respectively). The most common adverse reactions with Lialda when used as maintenance therapy were ulcerative colitis, headache, abnormal liver function test, and abdominal pain 

  • July 18, 2011

    Uses:

    Treatment of actinic keratosis on the face or balding scalp

    Graceway announced the FDA approval of a new strength of its imiquimod cream, 2.5%, for the treatment of actinic keratosis on the face or balding scalp. The cream is currently available in a 3.75% strength for the treatment of actinic keratosis and genital warts. Data were collected in four double-blind studies comparing the 2.5% and 3.75% creams versus placebo. Patients applied imiquimod 2.5% on a 2 weeks on, 2 weeks off, 2 weeks on dosing cycle, and results showed that patients in the 2.5% treatment group experienced fewer local skin reactions than with the higher strength formulation. In addition, 31% of patients using imiquimod 2.5% cream had complete clearance of actinic keratosis, compared with 6% of patients in the placebo group.

  • July 18, 2011

    FDA announced that the 2011–12 influenza vaccines have been approved. Six manufacturers will produce and distribute the vaccines in the U.S. These include Afluria by CSL Limited; Fluarix by GlaxoSmithKline; FluLaval by ID Biomedical Corporation; FluMist by MedImmune ; Fluvirin by Novartis; and Fluzone, Fluzone High-Dose, and Fluzone Intradermal by sanofi pasteur. The three strains selected for the upcoming season include A/California/7/09 (H1N1)-like virus (pandemic (H1N1) 2009 influenza virus), A/Perth /16/2009 (H3N2)-like virus, and B/Brisbane/60/2008-like virus. 

  • July 13, 2011

    Uses:

    Prophylaxis of deep vein thrombosis (DVT), treatment of DVT, and treatment of acute pulmonary embolism 

    Dr. Reddy’s Laboratories and Alchemia Limited announced FDA approval of fondaparinux sodium injection, the first and only bioequivalent generic version of GlaxoSmithKline’s Arixtra. The approval includes the 2.5 mg/0.5 mL, 5.0 mg/0.4 mL, 7.5 mg/0.6 mL, and 10 mg/0.8 mL doses of fondaparinux in prefilled color-coded, single-dose syringes with an automatic needle safety device. This new generic will be manufactured using a patented process developed by Alchemia. According to a company press release, competition is likely to be limited for the foreseeable future because of the complexity involved in manufacturing this generic product. 

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