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  • Drug makers file suit against Mylan over generic Vivelle-Dot

    PITTSBURGH — A group of drug makers have sued Mylan over its attempt to gain Food and Drug Administration approval for a generic menopause drug, Mylan said Tuesday.

  • FDA targets unapproved cough-cold, allergy drugs with Unapproved Drugs Initiative

    SILVER SPRING, Md. — The Food and Drug Administration has taken action against makers of prescription drugs for cough-cold and allergies that don’t have regulatory approval, the agency said Wednesday.

    The action is part of the agency’s Unapproved Drugs Initiative, which seeks to remove from the market drugs that have not received approval. In many cases, the drugs were marketed before the FDA adopted its current regulatory standards.

  • Report: FDA warns of long-term PPI use

    SILVER SPRING, Md. — The Food and Drug Administration is warning that long-term use of a class of drugs for gastroesophageal reflux disease may decrease levels of magnesium in the body and increase the risk of such side effects as seizures and heart rhythm problems, according to published reports.

    The reports quoted the FDA as saying that in a quarter of cases of proton-pump inhibitors depleting magnesium from the body, use of magnesium supplements did not bring levels back to normal, and use of the drugs had to be stopped.

  • Forest gets nod for COPD drug

    SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for chronic obstructive pulmonary disease made by Forest Labs, the agency said Tuesday.

  • Cold sore treatment Xerese enters market

    HUDDINGE, Sweden — Meda has launched a new cold sore treatment made by commercialization partner Medivir, Medivir said Tuesday.

    The Swedish drug maker launched Xerese (acyclovir and hydrocortisone), a topical combination product designed to treat recurrent herpes simplex labialis.

    Medivir said the U.S. market for cold sore products is $230 million, and it expected the drug to be successful, given Meda’s presence in the U.S. market.

  • GSK granted FDA approval for Promacta

    PHILADELPHIA — The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.

    The drug maker announced the approval of Promacta (eltrombopag) for chronic immune thrombocytopenic purpura, or ITP, in patients who have not responded adequately to other therapies. Chronic ITP results in increased destruction of inadequate production of platelets in the blood, creating an increased risk of bruising and bleeding.

    The FDA granted Promacta orphan drug designation in May 2008 and accelerated approval in November 2008.

  • Takeda's Edarbi approved as hypertension treatment

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for hypertension, also known as high blood pressure, the agency said Friday.

    The FDA approved Takeda’s Edarbi (azilsartan medoxomil).

  • Intuniv OKed as add-on therapy to treat ADHD

    PHILADELPHIA — The Food and Drug Administration has approved a new use for a Shire drug to treat attention deficit hyperactivity disorder, Shire said Monday.

    The FDA approved Intuniv (guanfacine) as an add-on therapy for children and adolescents already taking stimulants to treat ADHD, also known as an adjunctive therapy.

    The approval was based on a nine-week placebo-controlled study of the drug in which children and adolescents received it in combination with a stimulant.

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