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Regulatory and Washington

  • Mylan files for approval of generic gout drug

    PITTSBURGH — Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.

  • FDA approves new drug for chronic lymphocytic leukemia

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for leukemia made by Genentech, the agency said Friday.

    The FDA announced the approval of Gazyva (obinutuzumab) for treating patients with previously untreated chronic lymphocytic leukemia, in combination with the chemotherapy drug chlorambucil. The drug works by helping certain cells in the immune system attack cancer cells.

  • FDA approves two Novo Nordisk insulin pens

    PLAINSBORO, N.J. — The Food and Drug Administration has approved two new insulin pens made by Novo Nordisk, the Danish drug maker said Friday.

    Novo Nordisk announced the FDA approval of Novolog FlexTouch (insulin aspart [rDNA origin]) and Levemir FlexTouch (insulin detemir [rDNA origin]).

  • PTCB revises certification exam for pharmacy techs

    WASHINGTON — Medication safety and pharmacy information systems get more attention in the latest version of an exam for pharmacy technicians.

    The Pharmacy Technician Certification Board announced Friday updates to the Pharmacy Technician Certification Exam, based on the group's Job Analysis Study, which involves more than 25,000 pharmacy technicians from across the country and from different practice settings. The updated exam has nine knowledge groups known as domains, rather than three.

  • FDA report delves into personalized medicine

    SILVER SPRINGS, Md. — Earlier this year, the Food and Drug Administration approved a new drug for treating cystic fibrosis for patients who have a specific genetic mutation, but that also treats the underlying cause of the disease rather than the disease itself.

  • Council for Responsible Nutrition publishes statutory, regulatory guide

    WASHINGTON — A new book from a trade group representing makers of dietary supplements details the laws and regulations that govern the industry.

  • FDA issues plan to reduce drug shortages

    SILVER SPRING, Md. — The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.

  • Impax Labs, Tolmar receive FDA approval for generic version of Solaraze

    HAYWARD, Calif., and FORT COLLINS, Colo.  — Impax Labs and Tolmar announced that the Food and Drug Administration has given final approval to Tolmar's generic version of Solaraze (diclofenac sodium) gel in the 3% strength.

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