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Generics

  • BV Investment Partners becomes majority shareholder of ECRM; Greg Farrar named ECRM CEO

    SOLON, Ohio — Efficient Collaborative Retail Marketing on Tuesday announced that BV Investment Partners has become ECRM’s majority shareholder, effective immediately. Greg Farrar was named ECRM's CEO.

  • FDA marks GDUFA milestones

    SILVER SPRING, Md. — The Food and Drug Administration has made a significant dent in its large backlog of generic drug applications thanks to amendments to last year's reauthorization of the Prescription Drug User Fee Act, the agency said Tuesday.

  • FDA approves generic Alzheimer's disease drug

    SILVER SPRING, Md. — The Food and Drug Administration has approved a generic drug for treating Alzheimer's disease, FDA records showed.

    The agency announced the approval of Alvogen's donepezil hydrochloride, a generic version of Aricept, made by Pfizer and Eisai. The generic drug was approved in the 5 mg and 10 mg strengths.

    More than 20 other companies also make generic versions of Aricept. The drug is used to treat mild to moderate Alzheimer's, as well as severe forms of the disease.

     

  • FDA gives tentative approval to Mylan's generic Crestor

    SILVER SPRING, Md. — Mylan has received tentative approval for a generic version of a cholesterol drug made by AstraZeneca, according to Food and Drug Administration records.

    The FDA gave the tentative approval to Mylan's rosuvastatin calcium tablets in the 5 mg, 10 mg, 20 mg and 40 mg strengths. The drug is a generic version of AstraZeneca's Crestor, which had sales of $5.1 billion in 2012, according to IMS Health.

  • Patent settlements have saved more than $25 billion since 2005, IMS study finds

    WASHINGTON — The U.S. healthcare system has saved $25.5 billion over seven years from generic drugs launched under patent settlements between branded and generic drug manufacturers, according to a new study.

  • Impax appoints former FDA adviser to board

    HAYWARD, Calif. — Impax Labs has appointed Mary Pendergast to its board of directors, the generic drug maker said.

    Impax said Pendergast's appointment became effective last Wednesday. Pendergast is president of legal and regulatory consulting firm Pendergast Consulting. She previously served as deputy commissioner and senior adviser to the commissioner of the Food and Drug Administration for 18 years.

  • FDA issues fentanyl patch disposal guidelines

    NEW YORK — Nearly 30 children have been accidentally poisoned by opioid painkiller patches since 1997, according to the Food and Drug Administration, prompting the agency to issue disposal guidelines.

    The FDA listed the guidelines on its website, saying that unused fentanyl patches should be stored out of the reach and sight of children, while used patches should be folded, sticky sides together, and flushed down the toilet.

  • AMA adopts resolution on pharmacist drug inquiries

    NEW YORK — Inquiries by pharmacists with doctors regarding the rationale behind prescriptions, diagnoses and treatment plans are inappropriate, according to a new resolution by the American Medical Association.

    The AMA adopted the resolution at its 2013 annual meeting, calling such inquiries "an interference with the practice of medicine and unwarranted."

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