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Generics

  • Reports: 'Track and trace' may be part of PDUFA reauthorization

    NEW YORK — Federal and industry officials have been negotiating a federal track-and-trace system as part of a reauthorization of the Prescription Drug User Fee Act, according to published reports.

  • FDA approves generic Parkinson's disease drug made by Actavis

    MORRISTOWN, N.J. — The Food and Drug Administration has approved a treatment for Parkinson's disease made by Actavis, the drug maker said Friday.

    Actavis, which last month signed a deal with Watson Pharmaceuticals to be acquired for $5.6 billion, announced the approval and launch of ropinirole extended-release tablets in the 2-mg, 4-mg, 6-mg, 8-mg and 12-mg strengths.

    The drug is a generic version of GlaxoSmithKline's Requip XL, which had sales of about $59.4 million in 2011, according to IMS Health.

  • Dr. Reddy's launches generic version of Plavix

    HYDERABAD, India — Generic drug maker Dr. Reddy's Labs has launched a generic version of a drug used to prevent clotting of the blood.

    Dr. Reddy's announced Friday the launch of clopidogrel tablets in the 75-mg and 300-mg strengths. The drug is a generic version of Plavix, made by Bristol-Myers Squibb and Sanofi. As one of the first companies to submit a completed regulatory application for the 300 mg strength of the drug, Dr. Reddy's received 180 days of market exclusivity for it.

  • Mylan sponsors Drug Store News and Pharmacist Society to provide a new business networking platform for pharmacy schools and students

    PITTSBURGH and NEW YORK — The Drug Store News Group, the Pharmacist Society and Mylan Inc., one of the world's leading generics and specialty pharmaceutical companies, are pleased to announce an exclusive sponsorship to expand membership opportunities at PharmacistSociety.com — an online forum that supports and enhances professional networks for U.S.-based retail pharmacists, professional organizations and pharmacy companies.

  • Watson challenges Lo Loestrin Fe patent

    PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is challenging the patent protection of a contraceptive drug made by Warner Chilcott, Watson said Friday.

    The company announced that it had filed a regulatory application with the Food and Drug Administration for norethindrone acetate and ethinyl estradiol tablets in the 1-mg/0.01-mg strength and ethinyl estradiol and ferrous fumarate tablets in the 0.01-mg/75-mg strength. The treatment is a generic version of Warner Chilcott's Lo Loestrin Fe.

  • CDC: Chronic disease states less prevalent as education, household income rise

    ATLANTA — People with higher levels of education and higher income have lower rates of many chronic diseases compared with those with less education and lower income levels, according to "Health, United States, 2011" — the government’s annual comprehensive report on Americans’ health released Wednesday.

  • Wolters Kluwer launches mobile app edition of Nursing Drug Handbook

    AMBLER, Pa. — Wolters Kluwer Health has introduced what it called the first mobile application for the Nursing Drug Handbook, the company said Thursday.

    Published by Lippincott Williams & Wilkins, the app is available for Apple and Android devices and is a mobile version of the popular reference for nurses that includes weekly updates.

  • Sagent launches generic chemotherapy drug

    SCHAUMBURG, Ill. — Sagent Pharmaceuticals has launched a generic version of a chemotherapy drug, the company said Thursday.

    Sagent announced the launch of irinotecan injection, a generic version of Pfizer's Camptosar, in latex-free, preservative-free, single-dose vials.

    Various versions of the drug had sales of about $28 million during the 12-month period ended in March, according to IMS Health.

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