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Regulatory and Washington

  • NCPA applauds 'Today Show' segment on proper storage, disposal of medication

    ALEXANDRIA, Va. — A segment on NBC's "Today Show" that emphasized the importance of properly storing and disposing medication has received praise from the National Community Pharmacists Association.

  • Generic, authorized generic of Amrix launched

    PITTSBURGH — Drug maker Mylan has launched a generic treatment for muscle spasms, the company said Friday.

    Mylan announced the launch of cyclobenzaprine hydrochloride, a once-daily muscle relaxant, in the 15-mg and 30-mg strengths. The drug is a generic version of Cephalon’s Amrix, which had sales of about $125 million during the 12-month period ended in March, according to IMS Health.

  • FDA to debate pediatric APAP dosing during mid-week advisory committee meeting

    WASHINGTON — The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.

  • Taylor Wallace succeeds Andrew Shao at CRN

    WASHINGTON — The Council for Responsible Nutrition on Monday named Taylor Wallace to the post of senior director, scientific and regulatory affairs.

    “Dr. Wallace’s background will nicely complement that of our well-established scientific team, and we’re looking forward to the fresh perspective his background will provide,” CRN president and CEO Steve Mister said. “We were impressed with the amount of work he has published in his short career along with the relationships he has built within the scientific research community.”

  • Pharmacy's role in emergency preparedness underscored in statement to House subcommittee

    ALEXANDRIA — Pharmacies play a critical role in emergency preparedness. That was the key message in a statement issued this week by the National Association of Chain Drug Stores to the House of Representatives' Homeland Security Subcommittee on Emergency Preparedness, Response and Communications.

    The subcommittee held a hearing this week, titled "Taking Measure of Countermeasures: A Review of Efforts to Protect the Homeland Through Distribution and Dispensing of CBRN [chemical, biological, radiological or nuclear] Medical Countermeasures."

  • Mylan launches generic Risperdal M-Tab

    PITTSBURGH — Generic drug maker Mylan has launched a version of a drug used to treat schizophrenia, the company said Friday.

    Mylan announced the launch of risperidone orally disintegrating tablets in the 0.5-mg, 1-mg, 2-mg, 3-mg and 4-mg strengths.

    The drug is a generic version of Johnson & Johnson’s Risperdal M-Tab. Various versions of risperidone orally disintegrating tablets had sales of about $61 million in 2010, according to IMS Health.

  • Chain pharmacy lauds Obama administration's plan to curb Rx diversion, misuse

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced on Friday that it sent a letter to the White House Office of National Drug Control Policy in support of the administration's strategy to prevent and reduce prescription drug diversion and misuse. Last month, the administration released its report, "Epidemic: Responding to America's Prescription Drug Abuse Crisis," detailing its policy recommendations.

  • J&J recalls lots of Prezista amid odor reports

    HIGH WYCOMBE, United Kingdom — A subsidiary of Johnson & Johnson is recalling several batches of an HIV drug after reports of a strange odor that may have come from the shipping pallets.

    Janssen-Cilag International said it would recall five lots of Prezista (darunavir) due to consumer reports of a musty or moldy smell coming from them. The odor is believed to result from traces of the chemical TBA, which is used in the construction of the pallets. The recalled lots were found in Canada, the United Kingdom, Ireland, Germany and Austria.

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