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Regulatory and Washington

  • Mylan gets OK for generic Femara

    PITTSBURGH — Mylan has launched a generic treatment for breast cancer, the drug maker said Monday.

    Mylan announced the launch of letrozole tablets in the 2.5-mg strength, an adjuvant treatment for postmenopausal women with hormone receptor-positive early-stage breast cancer.

    The drug is the first generic version of Novartis’ Femara, which had sales of about $682 million in 2010, according to IMS Health.

  • Menactra approved for use in infants, toddlers

    SILVER SPRING, Md. — The Food and Drug Administration has approved the first vaccine for preventing meningococcal disease in children as young as 9 months old, the agency said.

    The FDA announced the approval of Menactra, made by Sanofi Pasteur, the vaccines arm of French drug maker Sanofi-Aventis. Meningococcal disease is a life-threatening illness caused by Neisseria meningitidis bacteria that infect the bloodstream and the lining surrounding the brain and spinal cord.

  • Pozen, AstraZeneca file suit against Dr. Reddy's over generic Vimovo

    CHAPEL HILL, N.C. — A generic drug maker is being sued for patent infringement for its version of a fixed-dose combination drug co-created by Pozen and AstraZeneca.

  • Tec Labs to cooperate with FDA over product's MRSA claims

    ALBANY, Ore. — In response to a Food and Drug Administration warning letter, Tec Labs announced on Thursday that the company plans to work with the agency regarding its StaphAseptic first-aid antiseptic and pain-relieving gel.

    The FDA on Wednesday issued a total of four warning letters, including the one to Tec Labs, to companies that manufacture and market products claiming to prevent infection from methicillin-resistant Staphylococcus aureus bacteria, or MRSA.

  • CDC: Half of all states have smoke-free worksites, restaurants and bars

    ATLANTA — By 2020 or sooner, the entire nation could have laws banning smoking in all indoor areas of private sector worksites, restaurants and bars, a study by the Centers for Disease Control and Prevention released Thursday has found.

    The projection is based on the rate at which states have been adopting comprehensive smoke-free laws. In just the past 10 years, 25 states and the District of Columbia have enacted these laws, the CDC reported.

  • Council for Responsible Nutrition, Natural Products Association respond to British Medical Journal meta-analysis

    WASHINGTON — Two associations representing dietary supplement companies criticized a British Medical Journal meta-analysis published April 20 that concluded calcium and vitamin D supplementation may increase risk of heart attack and stroke.

  • CDC kicks off Flu App Challenge

    ATLANTA — The Centers for Disease Control and Prevention on Thursday announced its CDC Flu App Challenge to identify innovative and creative uses of technology that would help raise awareness of influenza and/or educate consumers on ways to prevent and treat the flu. All told, the challenge will award up to $42,500 in prizes.

    The submission period runs through May 27; winners will be announced June 8.

  • Report: Lupin's generic Fortamet receives FDA nod

    NEW DELHI — The Food and Drug Administration has approved a diabetes drug made by Lupin Pharmaceuticals, according to published reports.

    The FDA approved Lupin’s metformin hydrochloride extended-release tablets, a generic version of Andrx Labs’ Fortamet.

    Fortamet had sales of $83 million in 2010, according to IMS Health.

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