| January 29, 2013 | News for the food and drug law community |
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| Drugs & Biologics |  |  |
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- FDA warns of liver injury risk from tolvaptan
Otsuka America Pharmaceutical's kidney drug Samsca, or tolvaptan, may cause irreversible and potentially deadly liver injury, and providers should promptly conduct liver tests on patients reporting symptoms, according to the FDA. Otsuka informed the FDA that three trial participants who took tolvaptan developed liver problems, and their conditions improved after they stopped taking the drug. Medscape (free registration)
(1/25)  
- EMA to consider blood clot risks of newer contraceptives
The European Medicines Agency will review third- and fourth-generation combined oral contraceptives' safety to decide if restricting their use is necessary. The move was requested by France, which wants to limit the newer contraceptives' use due to blood clots. "There is no reason for any woman to stop taking her contraceptive," the EMA said. "If a woman has concerns, she can discuss this with her doctor." Reuters
(1/28), PharmaTimes (U.K.)
(1/29)
- France to study deaths linked to acne drug
Health authorities in France are examining four thrombosis-caused deaths over the past 25 years that may be connected to the acne drug Diane-35, which is also used as a contraceptive. Diane-35, produced by Bayer, is sold in at least 116 countries. Reuters
(1/27)
- Report: China needs stronger standards for generic biologics
A report by the Pharmaceutical Association Committee criticizes China for its lax standards in approving generic versions of biological drugs, pointing out that generics can be registered as new products with lower testing requirements than the originals. "This regulation framework is inconsistent with global norms and can expose patients to unknown risk,” the report asserts. Bloomberg
(1/28)
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| Medical Devices | | |
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- EU approves lower-profile components of Gore's stent-graft
European regulators have granted W.L. Gore & Associates CE mark approval to market lower-profile components of its Gore Excluder AAA endoprosthesis, which is used to treat patients with abdominal aortic aneurysms. The approval applies to a 32-millimeter aortic extender and an ipsilateral leg that measures 31 millimeters in diameter. MassDevice.com (Boston)
(1/25)
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- Controlled Substances: FDA and DEA Regulation of Pharmaceuticals
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| Position Title | Company Name | Location |
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