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Regulatory and Washington

  • Ranbaxy settles cGMP issues with U.S. government

    GURGAON, India — Ranbaxy Labs said Wednesday that it had resolved long-standing issues concerning two of its manufacturing plants in India with the U.S. government.

  • Santarus applies for approval of ulcerative colitis drug

    SAN DIEGO — Drug maker Santarus has submitted a new drug application with the Food and Drug Administration for a treatment for ulcerative colitis, the company said.

    The application was for Uceris (budesonide) tablets in the 9-mg strength for moderate active UC. The company is developing the drug under a collaboration with Cosmo Technologies.

     

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  • Independents providing LTC could face challenges under newly proposed CMS regulations

    ALEXANDRIA, Va. — According to the National Community Pharmacists Association, changes governing long-term care facilities that recently were proposed by the Centers for Medicare and Medicaid Services could create turmoil for independent community pharmacies providing LTC services, the association stated in a release Wednesday.

  • FDA approves Takeda's Edarbyclor

    DEERFIELD, Ill. — The Food and Drug Administration has approved a new drug for high blood pressure made by Takeda, the drug maker said.

    The Japanese drug maker received approval for Edarbyclor (azilsartan medoxomil and chlorthalidone) for the treatment of high blood pressure, also known as hypertension. The company called it the only fixed-dose therapy that combines an angiotensin II receptor blocker with chlorthalidone, a diuretic, in a once-daily, single tablet. The company also markets Edarbi, which only contains azilsartan medoxomil.

  • Pfizer submits regulatory application for rheumatoid arthritis drug to FDA

    NEW YORK — Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

    The company said the FDA accepted a new drug application for tofacitinib for review. The agency also has provided an anticipated Prescription Drug User Fee Act action date of August 2012. Tofacitinib, which is a novel, oral JAK inhibitor, currently is under review by the European Medicines Agency.

  • Webinar: CRN, VIRGO to bridge GMP gap between industry action and FDA expectations

    WASHINGTON — The Council for Responsible Nutrition and VIRGO on Tuesday announced details for an industrywide webinar to examine key elements of good manufacturing practices for dietary supplements and offer advice as to what the industry can do to improve its record of inspections. 

    Moderated by Duffy MacKay, CRN VP scientific and regulatory affairs, the webinar will help companies better understand the intricacies of GMPs and will offer tips and best practices for passing Food and Drug Administration inspections.

  • PTCB to FSA holders: OTCs are still eligible expenses

    WASHINGTON — The Pharmacy Technician Certification Board on Tuesday announced a push to inform patients with practical solutions on how to best utilize remaining 2011 flexible spending account funds.

  • FDA approves Sandoz drug for fungal infections

    PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Sandoz for treating yeast and other fungal infections.

    Sandoz announced Monday the approval of voriconazole tablets in the 50-mg and 200-mg strengths, a generic version of Pfizer's Vfend.

    Branded and generic versions of the drug had sales of about $189 million during the 12-month period ended in October, according to IMS Health.

     

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