Intrinsa testosterone patch to be reviewed by FDA committee
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NEW YORK Men with sexual dysfunction have gotten help in the form of a pill. Now women with sexual dysfunction may get help in the form of a patch.
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A new study showing an increased risk of blood clots among women using a contraceptive skin patch has prompted the Food and Drug Administration to add that finding to the drugâs label.
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US Food and Drug Administration staff reviewers on Tuesday questioned clinical data for non-Hodgkin&#39;s lymphoma drug Marqibo, made by Inex Pharmaceuticals Corp.
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NEW YORK - A US Food and Drug Administration advisory panel rejected Procter &amp; Gamble&#39;s testosterone patch to treat female sexual dysfunction.
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US regulators say they will conduct a so-called fast-track review of testosterone patches for women suffering from impaired libidos.
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CHICAGO -- It&#39;s make or break time for Intrinsa this week, as the embattled FDA reviews the data on it and decides whether or not it can be marketed.
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Procter & Gamble Co.'s testosterone patch for boosting female sex drive needs longer-term testing for serious side effects before it can win approval, a U.S. advisory panel unanimously ruled on Thursday.
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German biotech firm Jerini AG said on Friday that U.S. regulators at the Food and Drug Administration have granted priority review of its Icatibant drug for the treatment of skin-swelling disease hereditary angioedema.
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A House of Representatives subcommittee is expected to take up legislation next week meant to bolster the Food and Drug Administration's ability to monitor prescription drug side effects, the panel's chairman said in a letter released on Thursday.
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Beleaguered pharmaceutical giant Merck &amp; Co. Inc. has appointed a special committee of board members and a retired federal judge to review the company&#39;s actions before it
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A hormone patch that works to restore a woman&#39;s sex drive should not be approved until more studies are completed to determine the drug&#39;s risks, US health advisers said Thursday.
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An FDA advisory panel voted unanimously not to approve Protcer &amp; Gamble&#39;s testosterone patch, Intrinsa, for the female treatment of low sex drive (libido).
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Staff members of the Food and Drug Administration on Wednesday issued a report raising several questions about an experimental drug from Procter &amp; Gamble (PG:NYSE - news - research) designed to improve sexual desire in women whose ovaries have been
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WASHINGTON : A skin patch providing sexual stimulation for menopausal women that promises to do what Viagra did for men will begin its approval procedure on Thursday at the Federal Drug Administration (FDA).
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An advisory panel to the Food and Drug Administration will meet today to decide whether a skin patch to heighten the sexual arousal of older women is safe and effective and should be licensed as a new drug.
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A new study showing an increased risk of blood clots among women using a contraceptive skin patch prompted the Food and Drug Administration on Friday to add that finding to the drug's label.
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The American Psychiatric Association commends the Food and Drug Administration, and in particular its Psychopharmacologic Drugs Advisory Committee and its Pediatric Advisory Committee, for its public hearing on safe antidepressant use in pediatric patients