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Regulatory and Washington

  • FDA: Dietary supplements distributed bear close resemblance to popular antibiotic

    TUCKER, Ga. — A recent Food and Drug Administration inspection prompted the recall of dietary supplements distributed by Multi-Mex Distributor, the company announced Monday. According to an FDA post, the supplements in question bore a close resemblance to antibiotics available in Mexico and may have been confusing to Hispanic consumers.

  • Surgeon general, NCL introduce Script Your Future campaign

    WASHINGTON — The National Consumers League and the U.S. surgeon general are launching a new campaign to educate patients about the risks of not properly taking their medications, the organization said.

  • Missouri's Rx-only PSE legislation moves to state Senate

    ST. LOUIS — Missouri’s House of Representatives on Monday voted 100 in favor and 50 opposed to reclassifying pseudoephedrine as a prescription-only remedy and subsequently moved the matter to the state Senate — this despite the fact that electronic track-and-trace has been up and running for the past six months, blocking more than 30,000 potentially illegal PSE purchases, stated Scott Melville, president and CEO of the Consumer Healthcare Products Association.

  • Genentech seeks regulatory approval for vemurafenib

    SOUTH SAN FRANCISCO, Calif. — Genentech is seeking approval for a new drug to treat skin cancer, the company said Wednesday.

  • APhA releases REMS white paper

    WASHINGTON — The American Pharmacists Association has published its white paper on risk evaluation and mitigation strategies, the group said.

  • Perrigo to settle litigation related to generic Cutivate

    ALLEGAN, Mich. — Drug maker Perrigo has reached a licensing agreement with Nycomed US that will allow it to launch a generic treatment for dermatitis in 2012, the company said.

    Perrigo said it agreed to settle all Hatch-Waxman litigation relating to its generic version of Cutivate (fluticasone) lotion with Nycomed, allowing it to launch under a licensing agreement in September 2012.

    Cutivate is used to treat dermatitis in patients ages 1 year and older and had sales of about $50 million during the 12-month period ended in February, according to Wolters Kluwer.

  • Report: Number of drug approvals by FDA may increase

    NEW YORK — The Food and Drug Administration expects to approve an increasing number of drugs, according to published reports.

    Reuters quoted FDA Center for Drug Evaluation and Research director Janet Woodcock as saying the number of drugs approved gradually could increase, already having reached a “nadir.” The report noted that 12 drugs had won approval this year so far, and Woodcock speculated that the agency would approve more than the 21 it approved last year.

  • FDA OKs Sanofi Pasteur's Fluzone Intradermal

    SWIFTWATER, Pa. — Sanofi’s vaccines division has won Food and Drug Administration approval for a vaccine designed for injection into the skin, the company said Tuesday.

    Sanofi Pasteur announced the FDA approval of Fluzone Intradermal (influenza virus vaccine), which injects the vaccine into the skin via a short, fine needle, also known as a microinjection.

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