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Regulatory and Washington

  • Bioniche Pharma launches generic Sandostatin

    PITTSBURGH — Mylan subsidiary Bioniche Pharma has launched an injectable treatment for a rare metabolic disorder, Mylan said Tuesday.

    Mylan announced the launch of octreotide acetate injection in prefilled syringes, a generic version of Novartis’ Sandostatin, used to treat the disorder acromegaly and suppress or inhibit severe diarrhea related to certain tumors. Acromegaly results from excess growth hormone produced in the pituitary gland, causing fatigue and weakness, body odor and carpal tunnel syndrome.

  • Senate repeals 1099 tax reporting requirement

    WASHINGTON — The U.S. Senate Tuesday voted to repeal a law that posed a burdensome tax reporting requirement for businesses.

    In an 87-12 decision, the legislative body passed H.R. 4, the Small Business Paperwork Mandate Elimination Act, sponsored by Rep. Dan Lungren, R-Calif. The bill repeals a provision in the Patient Protection and Affordable Care Act of 2010 that required businesses to file a Form 1099 with the Internal Revenue Service whenever they made noncredit-card payments totaling $600 or more to a vendor during a single year.

  • NACDS responds to proposed Rx labeling recommendations

    ALEXANDRIA, Va. — Following the release of U.S. Pharmacopeia's Proposed General Chapter Prescription Container Labeling recommendations, the National Association of Chain Drug Stores issued a letter to USP urging flexibility and an open dialogue with pharmacy and prescriber communities as review of the recommendations continues.

  • Intellipharmaceutics seeks to market generic Seroquel XR

    TORONTO — Canadian drug maker Intellipharmaceutics International is seeking approval for a generic version of a treatment for mental disorders.

    Intellipharmaceutics announced Monday that it had filed an application with the Food and Drug Administration for quetiapine fumarate extended-release tablets, a generic version of AstraZeneca’s Seroquel XR.

  • Watson receives FDA approval for Nulecit

    MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for iron deficiency anemia made by Watson Pharmaceuticals, Watson said Thursday.

    The drug maker announced the approval of Nulecit (sodium ferric gluconate complex in sucrose), an injectable and generic version of Sanofi-Aventis’ Ferrlecit.

    The drug is used to treat iron deficiency anemia in adults and children ages 6 years and older undergoing chronic hemodialysis and receiving supplemental epoetin therapy.

  • Jaeger resigns from CEO post at NCPA

    ALEXANDRIA, Va. — Just four months after being appointed EVP and CEO of the National Community Pharmacists Association, Kathleen Jaeger is making an exit.

    The NCPA said that Jaeger will be leaving the organization to pursue other opportunities. Effective immediately, Douglas Hoey, who has served as NCPA's COO since 2005, will assume the chief executive role.

  • USDA features Purell product as BioPreferred

    AKRON, Ohio — The U.S. Department of Agriculture has chosen Purell green certified instant hand sanitizer foam as a featured product for the formal launch of its new BioPreferred label program.

    USDA deputy secretary Kathleen Merrigan made the announcement Thursday at a biobased product meeting in Glenwillow, Ohio.

  • Julie Philp joins NACDS

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores has hired Julie Philp as director of federal affairs to bring additional pharmacy and legislative expertise to the government affairs team. She joins NACDS on April 11.

    "Julie is a seasoned advocate with experience in pharmacy and on Capitol Hill, and she will bring a wealth of expertise to NACDS," stated NACDS president and CEO Steve Anderson. "NACDS members will enjoy working with Julie, and we are pleased to welcome her to NACDS' highly effective team."

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