The FDA is advancing the government’s effort to create electronic health records for Americans within the next decade by making it easier to access and share drug information more efficiently.
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The FDA is adopting the Systematized Nomenclature of Medicine (SNOMED) as the standard computerized medical vocabulary system for coding important terms in the Highlights [...]
At least 26.5 million prescriptions of the sleeping aid zoldipem tartrate (Ambien, sanofi aventis) were filled this past year, but some users nationwide have experienced bizarre side effects of sleepwalking, sleep eating, and memory loss from this powerful hypnotic agent.
New York City Attorney Susan Chana Lask filed a class action complaint in the Southern District [...]
The FDA is advising patients with epilepsy of a potential hazard caused by cracks in the applicator tips of diazepam rectal gel (Diastat AcuDial, Valeant). These cracks can result in the leakage of gel while it is being applied; this may cause patients to not get enough of the medication to control seizures.
The prefilled syringes [...]
The FDA has approved a supplemental New Drug Application for somatropin (of rDNA origin for injection) (Genotropin) to treat growth failure associated with Turner syndrome in patients whose bones are still capable of growing.
The approval was based on two randomized, open-label, clinical trials in 38 children of short stature with Turner syndrome. Both studies demonstrated [...]
The FDA has announced its approvals of this year’s seasonal influenza vaccines, which include the new strains of virus judged likely to cause flu in the Northern Hemisphere in 2006 and 2007. This season’s formulation includes one strain from last year’s vaccine and two new strains.
Four vaccine manufacturers will be able to market their vaccines [...]
Coagulation factor VIIa (recombinant) (NovoSeven, Novo Nordisk) is the first recombinant therapy to be approved for the treatment of bleeding episodes and for the prevention of bleeding in patients with acquired hemophilia who are undergoing invasive surgical procedures.
First introduced in 1999, NovoSeven is currently indicated for the treatment of bleeding episodes in hemophilia A or [...]
Posaconazole oral suspension (Noxafil, Schering-Plough) is now approved for patients with oropharyngeal candi-diasis, including infections refractory to itraconazole and/or fluconazole.
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