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FDA panel declines to recommend new approval for J&J anticlotting drug
RARITAN, N.J. — A Food and Drug Administration expert panel has recommended against expanding the approval of a Johnson & Johnson drug, the company said.
J&J subsidiary Janssen Research & Development said the FDA's Cardiovascular and Renal Drugs Advisory Committee voted against recommending approval of Xarelto (rivaroxaban) combined with antiplatelet drugs to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome.
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FDA approves treatment for vaginal fungus infections
ALLEGAN, Mich. — The Food and Drug Administration has approved a generic treatment made by Perrigo for fungal infections of the vagina, the company said.
Perrigo announced the approval of butoconazole nitrate 2% vaginal cream, a generic version of KV Pharmaceutical's Gynazole-1, used to treat vulvovaginal candidiasis, an infection caused by Candida fungus. KV voluntarily discontinued selling the drug in January 2009 due to manufacturing problems.