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January 28, 2013News for the food and drug law community

  Drugs & Biologics 
  • Overactive bladder drug wins OTC approval, but only for women
    Merck & Co. obtained FDA approval to market an over-the-counter version of Oxytrol for women ages 18 and older with overactive bladder. The OTC product, which will be sold as Oxytrol for Women, is a patch that contains oxybutynin, an anticholinergic agent that helps relax the bladder muscle. Men will continue to need a prescription to buy the drug. Prostate cancer diagnosis could be delayed if men mistake the cause of their urination problems. Reuters (1/25), MedPage Today (free registration) (1/25) Email this Story
  • Takeda gains FDA OK for 3 formulations of type 2 diabetes drug
    The FDA has granted Takeda Pharmaceuticals approval for its type 2 diabetes drug alogliptin as a standalone medication, and as an add-on to metformin in its Kazano formulation and with pioglitazone under the name Oseni. Alogliptin by itself will be branded as Nesina. Reuters (1/25) Email this Story
  • FDA expands approval for childhood leukemia drug
    The FDA approved Friday the expanded use of Novartis' leukemia drug Gleevec to include children newly diagnosed with Philadelphia chromosome positive acute lymphoblastic leukemia. The drug should be combined with chemotherapy and carries a risk of several adverse reactions, including liver toxicity and infections, the agency said. Bloomberg Businessweek (1/25) Email this Story
  • India's FDA prohibits distribution, sale of batches of 5 drugs
    The Indian state of Maharashtra's FDA blocked the sale and distribution of batches of five treatments over concerns about quality and violations of the Drug and Cosmetic Act. The state's drugmakers have been requested to pull the medicines intended to treat diabetes, malaria, cough and cold, and names and batch numbers were shared with health care providers. The Times of India (1/27) Email this Story
  Food & Dietary Supplements 
  Medical Devices 
  • Bioness' device gets FDA OK for treating pediatric foot drop
    Bioness has obtained 510(k) clearance from the FDA for its L300 Foot Drop System to be used in treating foot drop in pediatric patients with cerebral palsy and other neurological diseases. The neurostimulation device, which already has been cleared for adult use, helps restore foot mobility by sending electric signals to stimulate the affected leg's muscles. Medscape (free registration) (1/25) Email this Story
  • EU widens CE mark approval for Medtronic's vascular stent
    European regulators have given Medtronic CE mark approval for its Complete SE vascular stent to be used in the lower extremities, particularly the proximal popliteal and superficial femoral arteries. The self-expanding stent previously was approved for iliac artery applications in Europe. In the U.S., it is approved for iliac artery use and is under review for use in the legs. (1/25) Email this Story
  • Russian lawmakers back ban on public smoking, tobacco advertising
    Russian lawmakers supported a bill that would prohibit smoking in public spaces such as cafes and bars. The law is part of an effort to promote healthier living in the country, which trails only China as the biggest market for tobacco. The law, pushed by President Vladimir Putin, would prohibit tobacco advertising and limit sales at kiosks. Reuters (1/25) Email this Story
  Hot Topics 

Top five news stories selected by FDLI SmartBrief readers in the past week.

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  FDLI Items 
  • 2013 conference calendar announced -- Speak, register & save the dates!
    There are plenty of speaking opportunities available for this year's FDLI conferences. Please e-mail our development team if you are interested in participating or have any session/program ideas. FDLI members routinely receive at least a 20% discount on FDLI conferences, webinars and publications. Upcoming programs include:
    • Food Week 2013 | Feb. 5-8 | Washington, D.C.
    • Pharmacy Compounding: An FDLI Dialogue | Feb. 12 | Washington, D.C. or via teleconference
    • Medical Device Compliance, Regulation and Litigation Conference | March 4 | Washington, D.C.
    • Introduction to Drug Law and Regulation | April 3-4 | Washington, D.C.
    • Introduction to Medical Device Law and Regulation | April 3-4 | Washington, D.C.
    • FDLI Annual Conference | April 23-24 | Washington, D.C.
    • FDLI International Conference | June 10-11 | Beijing, China
    • Advertising & Promotion Conference | Sept. 16-17 | Washington, D.C.
    • Food Advertising: Claims, Litigations and Strategies | Oct. 8 | Washington, D.C.
    • FDA Regulation of Tobacco Products | Oct. 17 | Washington, D.C.
    • Enforcement, Litigation and Compliance | Dec. 10-11 | Washington, D.C.
    Email this Story
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--Diana Trilling,
American literary critic and author

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