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Generics

  • Suit to block approval of generic Copaxone dismissed

    WASHINGTON — Teva Pharmaceutical on Wednesday was denied in its suit to block approval of Mylan's and Sandoz' generic Copaxone, a multiple sclerosis drug, 10 days before the patent on the medication expires, according to a Bloomberg report published Thursday morning

    The court ruled that the suit had been filed prematurely and could be refiled at a later date, according to the report. 

  • Mylan launches olanzapine tablets

    PITTSBURGH — Mylan on Wednesday announced that it has launched olanzapine orally disintegrating tablets in 5-mg, 10-mg, 15-mg and 20-mg strengths. The drug is the generic version of Zyprexa Zydis tablets from Eli Lilly and Co.

    The drug is used for the treatment of schizophrenia or the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. Olanzapine ODT had U.S. sales of $120.8 million for the 12 months ending March 31, 2014, according to IMS Health.

  • CDC: Half of all Americans take one or more prescription medications

    ATLANTA — About half of all Americans reported taking one or more prescription drugs in the past 30 days during 2007-2010, and 1-in-10 took five or more, according to "Health, United States, 2013," the government’s annual, comprehensive report on the nation’s health that was released Wednesday. Use increased with age: 1-in-4 children took one or more prescription drugs in the past 30 days compared to 9-in-10 adults aged 65 years and older.

    The annual growth in spending on retail prescription drugs slowed from 14.7% in 2001 to 2.9% in 2011.

  • FDA issues guidance on using pharmacology data for biosimilar products

    ROCKVILLE, Md. — The Food and Drug Administration moved one step closer to establishing a biosimilar pathway with a new guidance document explaining how to use clinical pharmacology data to show similarity to a reference product, according to a report published by Regulatory Focus on Tuesday. 

  • Dr. Reddy's announces senior level changes

    HYDERABAD, India — Dr. Reddy's Labs on Wednesday announced that it has named Satish Reddy as chairman of the board. Reddy previously held the position of vice-chairman, managing director & COO. GV Prasad will continue to serve as CEO and provide leadership to the company in an executive capacity. He has also been named co-chairman and managing director.

  • Progress report: Transatlantic Taskforce on Antimicrobial Resistance has adopted 17 recommendations

    WASHINGTON — The U.S. Department of Health and Human Services and the European Commission on Tuesday released the first progress report of the Transatlantic Taskforce on Antimicrobial Resistance. The report renews the commitment of U.S. and European Union health authorities to pursue specific goals in their joint battle against antimicrobial resistance.  

  • American College of Physicians and partners seek to improve immunization rates

    PHILADELPHIA — The American College of Physicians, CECity and Pfizer on Wednesday announced a new initiative designed to increase adult immunization rates. 

  • Actavis names senior management team for combined Actavis, Forest Laboratories company

    DUBLIN — Actavis on Wednesday announced the proposed senior management team that will lead the specialty pharmaceutical company pending the successful close of the acquisition of Forest Labs, which is anticipated at mid-year. Following the close, Paul Bisaro, chairman and CEO of Actavis, will become executive chairman. Brent Saunders, currently CEO and president of Forest, will become CEO and president, and a member of the board of directors. Robert Stewart, president, Actavis global operations, will become COO.

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