Which is more effective in preventing hepatotoxicity for patients with acute generic acetaminophen poisoning: 20-hour intravenous (IV) or 72-hour oral – acetylcysteine? According to a Canadian study, it’s important to know when the overdose occurred.
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Daiichi Sankyo, Inc., has announced the approval of its supplemental New Drug Application (sNDA) for colesev-elam HCl (Welchol) to be used as an adjunct to diet and exercise, as mono-therapy or with a statin, to reduce elevated low-density lipoprotein-cholesterol (LDL-C) levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia who have not responded to a trial of diet therapy.
Pralatrexate (Folotyn, Allos) has been approved as the first agent to treat peripheral T-cell lymphoma (PTCL), often an aggressive type of non-Hodgkin’s lymphoma. Pralatrexate was designated as an orphan drug under the agency’s accelerated approval process.
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The FDA has approved Berinert, a C1-esterase inhibitor, for adolescents and adults with acute abdominal attacks and facial swelling associated with a potentially life-threatening genetic disease, hereditary angioedema (HAE). This protein product is derived from human plasma. Attacks can occur spontaneously or during stress, surgery, or infection in patients with HAE. Berinert regulates clotting and inflammatory reactions that, when impaired, can lead to local tissue swelling.
Berinert is contraindicated in patients with a history of life-threatening hyper sensitivity reactions to C1-esterase inhibitors. Adverse reactions may include subsequent HAE attacks, headache, abdominal pain, nausea, muscle spasms, pain, diarrhea, and vomiting.
Source: FDA, October 12, 2009
