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)

• 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)

• FDA OKs wider use of Pfizer's Prevnar 13 vaccine
  The FDA approved the use of Pfizer's pneumococcal conjugate vaccine Prevnar 13 in patients ages 6 to 17. The vaccine offers protection against pneumonia, ear infection and other diseases caused by 13 strains of Streptococcus pneumoniae. Reuters (1/25), Pharmaceutical Business Review Online (1/28)

• 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)

• 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)

Food & Dietary Supplements

• Food producer pulls chicken breasts due to metal pieces
  Advance Pierre Foods recalled about 1,200 pounds of fried chicken breasts after buyers found pieces of a metal tool that fell into a grinder. The products were distributed in Texas, Oklahoma, Missouri, Louisiana and Kansas. FoodSafetyNews.com (1/26)

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)

• FDA wants to exempt certain scleral plugs from 510(k) process
  Certain scleral plugs, which are used to temporarily seal surgical eye incisions, would be exempted from the 510(k) clearance process under a proposal released by the FDA. The proposed rule, which is up for comment through April 25, applies to scleral plugs with surgical grade stainless steel construction that may be coated with titanium, silver or gold. MassDevice.com (Boston) (1/25)

• 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. CardiovascularBusiness.com (1/25)

Tobacco

• 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)

Hot Topics

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

• Final FDA rule on device, drug and biologic combos is available (MassDevice.com (Boston))

• Canadian guidance covers use of foreign data in drug reviews (Financial Post (Canada))

• FDA allows deadline to seek rehearing to expire in off-label case (Pharmalot.com)

• FDA: Low prices contribute to generic drug shortages (MedPage Today (free registration))

• First botanical drug gets FDA nod (Natural News)

• Results based on number of times each story was clicked by readers.

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.
  

Position Title Company Name Location FDA Associate K&L Gates Multiple Locations, United States Sales Engineer 108473-02 UTC Climate, Controls & Security Carrier Corporation Austin, TX Food and Drug Associate Hunton & Williams LLP Washington, DC Compliance Counsel - Privacy Otsuka Princeton, NJ Corporate Attorney Otsuka Rockville, MD Corporate Attorney Otsuka Princeton, NJ Regulatory Consultant The Weinberg Group Washington, DC

Click here to view more job listings.

SmartQuote

There's much to be said for challenging fate instead of ducking behind it." --Diana Trilling, American literary critic and author