Tag: FDA

FDA warns Avon to smooth out claims on skin care products

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(Reuters) – The U.S. Food and Drug Administration warned beauty products company Avon Products Inc to stop advertising its Anew range of skin care products using language that makes them sound like drugs. In September, the regulator had warned L’Oreal SA for making similar claims. The FDA reviewed the company’s website in August, and objected to claims made about the products Anew Clinical Advanced Wrinkle Corrector, Anew Reversalist Night Renewal Cream, Anew Reversalist Renewal Serum, Anew Clinical Thermafirm Face Lifting Cream, and Solutions Liquid Bra Toning Gel. …

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FDA advisers back NPS’s drug for short bowel syndrome

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(Reuters) – U.S. drug advisers on Tuesday backed a drug to treat a rare and serious bowel disorder for which there is no long-term treatment available in the United States. A panel of outside advisers to the U.S. Food and Drug Administration agreed that NPS Pharmaceuticals Inc had demonstrated that the drug is safe and improves absorption of fluid and nutrients in the intestines of adults with short bowel syndrome. The 12-member panel voted unanimously in the drug’s favor. The FDA usually follows the advice of expert panels. …

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More drugs may be linked to meningitis outbreak: FDA

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A sign for pharmaceutical compounding company NECC, a producer of the steroid methylprednisolone acetate, is seen in Framingham, MassachusettsCHICAGO/NEW YORK (Reuters) – Two other drugs made by the Massachusetts pharmacy at the center of a deadly meningitis outbreak may be linked to the disease, U.S. health regulators said on Monday, potentially widening the scope of the health crisis. The Food and Drug Administration said it was looking into reports of a patient with possible meningitis who received an injection of a different steroid than the one found to have caused 15 deaths. …

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FDA warns against use of Stryker surgical suction systems

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(Reuters) – U.S. health regulators warned on Friday against the use of systems made by Stryker Corp for removing surgical waste from patients after receiving reports of one death and one serious injury due to tissue damage. The Stryker systems, called Neptune 1 Silver and Neptune 2 Ultra Waste, use powerful suction to collect and remove surgical fluid waste in operating rooms and smoke at surgical sites caused by electrocautery or laser devices. …

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FDA approves Medivation prostate cancer drug

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(Reuters) – A novel prostate cancer drug developed by Medivation Inc and Astellas Pharma Inc has been approved by the U.S. Food and Drug Administration for men whose cancer has spread despite treatment with hormone therapy and chemotherapy, the agency said on Friday. Approval of the pill, to be sold under the brand name Xtandi, comes three months ahead of the agency’s late-November decision deadline and sent shares of Medivation up 7.6 percent. Wall Street analysts, on average, have forecast Medivation’s sales of the drug at $1.2 billion by 2017, according to Thomson Pharma. …

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FDA warns against use of Pfizer’s Revatio in children

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(Reuters) – U.S. health regulators recommended against use of Pfizer Inc’s pulmonary arterial hypertension (PAH) drug Revatio in children up to 17 years of age, saying it had a higher risk of death when taken in a high dose. While the drug has never been approved for treatment of PAH in children, the U.S. Food and Drug Administration’s warning is against off-label use of the drug. …

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