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  • Teva sales increase by 2%

    JERUSALEM — Teva Pharmaceutical Industries had $5.1 billion in sales and $711 million in profits in third-quarter 2013, the Israeli drug maker said.

  • Impax Labs, Tolmar receive FDA approval for generic version of Solaraze

    HAYWARD, Calif., and FORT COLLINS, Colo.  — Impax Labs and Tolmar announced that the Food and Drug Administration has given final approval to Tolmar's generic version of Solaraze (diclofenac sodium) gel in the 3% strength.

  • Review supports pharmacogenomic testing for some psychiatric drugs, Assurex Health says

    MASON, Ohio — A personalized medicine company said a new study justifies clinical use of pharmacogenomic testing to help predict patients' response to psychiatric medications and improve treatment outcomes.

  • FDA issues plan to reduce drug shortages

    SILVER SPRING, Md. — The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.

  • GSK, Theravance launch Breo Ellipta

    RESEARCH TRIANGLE PARK, N.C. — A once-daily inhaler for chronic obstructive pulmonary disease has become available, the makers of the inhaler said Wednesday.

    GlaxoSmithKline and Theravance announced the availability of Breo Ellipta (fluticasone furoate; vilanterol), for long-term maintenance treatment of airflow obstruction in patients with COPD, a term that encompasses chronic bronchitis and emphysema. The drug is not meant for treating acute bronchospasm or asthma, the companies said.

  • Reports: Takeda sues Amneal over generic version of Colcrys

    NEW YORK — Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

    Law360 reported that Takeda Pharmaceuticals USA had sued Amneal in the U.S. District Court for the District of Delaware over the drug Colcrys (colchicine), used to treat gout and familial Mediterranean fever.

  • FDA approves Lundbeck's Sabril in children

    DEERFIELD, Ill. — The Food and Drug Administration has approved a drug made by Lundbeck for treating a form of epilepsy in children, the drug maker said.

    Lundbeck announced the approval of Sabril (vigabatrin) as an add-on therapy for refractory complex partial seizures in children ages 10 years and older who have not responded adequately to other treatments, as long as the benefit of treatment outweighs the risk of vision loss. The drug was already approved for treating the same condition in adults in 2009.

  • FDA introduces e-learning program about untruthful, misleading drug ads

    SILVER SPRING, Md. — The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.

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