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Generics

  • Mallinckrodt receives FDA approval for generic Duragesic

    ST. LOUIS — The Food and Drug Administration has approved a painkiller delivered through a skin patch made by Mallinckrodt, the generic drug maker said Friday.

    Mallinckrodt, part of Covidien, said the FDA approved its fentanyl transdermal system patch.

    The patch is a generic version of Johnson & Johnson’s Duragesic. The drug, an opioid and Class II controlled substance, is used for managing persistent, moderate-to-severe pain that requires continuous opioid administration.

  • Actavis OKed to market generic Protonix

    MORRISTOWN, N.J. — Actavis has received approval from the Food and Drug Administration to market a generic version of a popular gastroesophageal reflux disease treatment.

    The generic drug maker said it would market pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths. The drug is the generic equivalent of Pfizer's Protonix, which had U.S. sales of approximately $1.6 billion for the 12 months ended Dec. 31, 2010, according to IMS Health.

    Actavis said it would distribute the drug soon.

  • Court: Watson's generic OTC decongestant does not infringe on branded versions

    MORRISTOWN, N.J. — Over-the-counter generic versions of a line of products used to treat congestion do not infringe on the patents covering the branded versions, a federal court ruled Wednesday.

  • Report: Sandoz has as many as 10 follow-on biologics in works

    NEW YORK — Sandoz is developing as many as 10 new follow-on biologics, according to published reports.

    Reuters, citing an interview with Sandoz head Jeff George in the German newspaper Handelsblatt, said the generics arm of Swiss drug maker Novartis had eight to 10 new biosimilar molecules in development.

  • Teva reports Q4, full-year results

    JERUSALEM — Drug maker Teva on Tuesday said its North American sales during the fourth quarter ended Dec. 31 drove the drug maker's financial well-being.

  • FDA approves Hospira's generic Hycamtin

    LAKE FOREST, Ill. — The Food and Drug Administration has approved a generic cancer drug from Hospira.

    The drug maker announced the approval of topotecan injection for treating small-cell lung cancer sensitive disease after first-line chemotherapy has failed.

    The drug is a generic version of GlaxoSmithKline’s Hycamtin, which had sales of more than $140 million in 2010, according to Hospira.

  • Generics, specialty drugs drive AmerisourceBergen's Q1

    VALLEY FORGE, Pa. — AmerisourceBergen on Friday reported revenue of $19.9 billion, up 2.9%, for the first quarter ended Dec. 31.

  • Elite granted FDA approval for generic Adipex-P

    NORTHVALE, N.J. — The Food and Drug Administration has approved a generic weight-loss drug made by Elite Pharmaceuticals.

    Elite announced Friday the approval of phentermine hydrochloride in the 37.5-mg strength, a generic version of Teva’s Adipex-P.

    Branded and generic versions of the drug had sales of around $40 million in 2010, according to Elite.

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