Actelion withdraws its application for an extension of indication for Zavesca
The European Medicines Agency (EMEA) has been formally notified by Actelion of its decision to withdraw its application for an extension of indication for the centrally authorised medicine Zavesca (miglustat).
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FDA Licenses New Hemophilia Treatment
The U.S. Food and Drug Administration licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals, almost exclusively males, in the United States.
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Risk of peripheral neuropathy with Sebivo (telbivudine)
The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended that new warnings be included in the product information for Sebivo (telbivudine), from Novartis Europharm Ltd. This warning is intended to inform doctors about the risk of peripheral neuropathy in patients with chronic hepatitis B who are being treated with Sebivo.
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EMEA recommends new warnings and contraindications for rosiglitazone
The European Medicines Agency (EMEA) has recommended updating the product information for rosiglitazone-containing antidiabetic medicines. Rosiglitazone is available in the European Union as Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate/metformin) and Avaglim (rosiglitazone maleate/glimepiride).
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EMEA recommends withdrawal of marketing authorisations for cough medicines containing clobutinol
Finalising a review of the safety of clobutinol-containing cough medicines in the European Union (EU), the European Medicines Agency (EMEA) concluded that the risks of these medicines are greater than their benefits and recommended that the marketing authorisations for these medicines be withdrawn throughout the EU.
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FDA Warns Procter & Gamble about Unlawful Marketing of Product for School Children
The U.S. Food and Drug Administration (FDA) sent a warning letter to Procter & Gamble for making unlawful claims about its Vicks Early Defense Foaming Hand Sanitizer (Early Defense) product. The agency says the product's claims and directions for use cause it to be an unapproved new drug under the Federal Food, Drug, and Cosmetic Act. It cited specifically Procter & Gamble promotion of Early Defense for use by schoolchildren to prevent colds and to provide antimicrobial activity for up to three hours.
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FDA Approves New Uses for Evista
The U.S. Food and Drug Administration approved Evista (raloxifene hydrochloride) for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. Evista is only the second drug approved to reduce the risk of breast cancer.
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The European Medicines Agency (EMEA) has been formally notified by Actelion of its decision to withdraw its application for an extension of indication for the centrally authorised medicine Zavesca (miglustat). 
The U.S. Food and Drug Administration licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals, almost exclusively males, in the United States.