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Regulatory and Washington

  • Report: Federal judge hears arguments in ESI-Medco merger case

    NEW YORK — A federal judge in Pittsburgh will rule "later" on whether to block or allow a merger between pharmacy benefit managers Medco Health Solutions and Express Scripts, and is considering a request by two trade groups seeking to keep Medco's operations and assets separate from ESI while the lawsuit is pending, according to published reports.

  • NCPA addresses pharmacy crime issue with new Protect Your Pharmacy Now! program resources

    ALEXANDRIA, Va. — The National Community Pharmacists Association plans to provide its members with new resources to enhance pharmacy safety following the debut of a news segment that highlighted the growing frequency of pharmacy crime.

  • FDA approves Watson diarrhea drug

    PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic version of a drug for diarrhea made by Watson, the company said Tuesday.

    Watson announced the approval of vancomycin hydrochloride capsules in the 125-mg and 250-mg strengths. Vancomycin hydrochloride is used to treat diarrhea associated with Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains.

  • Lawsuit challenging ESI-Medco merger begins

    NEW YORK — Pharmacies hoping to block the merger between pharmacy benefit managers Express Scripts and Medco Health Solutions got their day in court Tuesday, according to published reports.

    Bloomberg reported that a hearing in the U.S. District Court for the Western District of Pennsylvania began in Pittsburgh, with the National Association of Chain Drug Stores, the National Community Pharmacists Association and several independent pharmacies hoping to stop the $29.1 billion merger, which the Federal Trade Commission approved last week.

  • FDA approves labeling change for Novo Nordisk diabetes drug

    PRINCETON, N.J. — The Food and Drug Administration has approved a change to the label of a Novo Nordisk drug stating that it offers superior blood-sugar control to a competing drug made by Merck, based on results of two clinical studies, Novo Nordisk said Monday.

  • CRN urges FDA to reconsider provisions in New Dietary Ingredient Draft Guidance

    WASHINGTON — The Food and Drug Administration's New Dietary Ingredient Draft Guidance should not give the agency pre-market approval over new dietary supplement products, the Council for Responsible Nutrition claimed Monday in a commentary published in Regulatory Toxicology and Pharmacology, the official journal of the International Society of Regulatory Toxicology and Pharmacology.

  • NAD refers company making unsubstantiated disease-state claims to FTC

    NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Monday referred advertising for Serranol dietary supplement, marketed by Good Health Naturally, to the Federal Trade Commission for further review after the company declined to fully participate in a National Advertising Division review of its advertising claims.

  • Wall Street Journal endorses ESI-Medco merger; retail pharmacy responds

    NEW YORK — The National Association of Chain Drug Stores and the National Community Pharmacists Association on Monday wrote the Wall Street Journal regarding the paper's endorsement last week of the Express Scripts-Medco merger approval.

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