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Generics

  • Drug approvals low in 2010

    NEW YORK — This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.

    The Wall Street Journal reported that 21 new drugs were approved through the year, compared with 25 in 2009 and 24 in 2008. The lag came in part due to stricter safety regulations, the newspaper reported.

  • FDA rejection of lower-dose Copaxone will likely ward off generic competition

    NEW YORK — One door closes; another door, well, closes. And that appears to be good news for Teva. Recent news that the Food and Drug Administration has rejected the drug maker's application for a new indication for multiple sclerosis drug Copaxone likely will mean the agency will not be so quick to approve a generic version of the drug without requiring a generic company to perform full clinical trials.

  • Marsh implements generic drug pricing offer

    INDIANAPOLIS — Marsh Supermarkets recently implemented a $3.99/$9.99 generic drug pricing offer for 30-day and 90-day prescriptions, respectively.

    The program applies to a designated list of generic drugs at commonly prescribed dosages (higher dosages cost more).

  • Takeda settles patent suits relating to Actos

    DEERFIELD, Ill., and OSAKA, Japan — Takeda and its subsidiary settled the patent suits it brought against generic drug makers that sought to develop their own versions of its diabetes treatment.

  • Court blocks AstraZeneca's suits over Crestor

    NEW YORK — A judge recently blocked AstraZeneca from attempting to impede the development of generic versions of its popular cholesterol drug, according to published reports.

  • URAC revises accreditation programs

    WASHINGTON — A healthcare accrediting organization is revising three products in its Pharmacy Quality Management suite of programs.

    URAC said its pharmacy committee approved revisions to its mail service, specialty pharmacy, and workers' compensation and property and casualty for pharmacy benefit management accreditation programs. The products revised include:

    • Mail-service pharmacy, version 2.0;

    • Specialty pharmacy, version 2.0; and

  • FDA releases annual 'Generic Drug Roundup'

    SILVER SPRING, Md. — Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

    The roundup is an annual highlighting of what the agency considers the most significant generic drug approvals.

  • Reform will bolster pharmacy, GAO confirms

    ALEXANDRIA, Va. — A study by the Government Accountability Office confirmed that the health-reform law enacted earlier this year established a more reasonable reimbursement level for pharmacies dispensing generic drugs to patients covered by Medicaid. But pharmacy retailers still face the continued threat of further Medicaid cuts at the state level, the independent pharmacy lobby warned Friday.

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