Final approval has been granted for CIP-Fenofibrate (Lipofen, Cipher Pharmaceuticals), a novel formulation of the active ingredient fenofibrate, which is used in the treatment of hyperlipidemia. Three dosages were approved: 50, 100 and 150 mg. The 150-mg strength is equivalent to Abbott’s Tricor 160 mg (under fed, not fasting, conditions). The new agent’s absorption is [...]
The U.S. Food and Drug Administration (FDA) has approved an Abbreviated New Drug Application (ANDA) for Azithromycin for Injection (American Pharmaceutical Partners), the generic equivalent of Pfizer’s Zithromax generic. Azithromycin drug is indicated for the treatment of community-acquired pneumonia and pelvic inflammatory disease when caused by susceptible microorganisms. The product will be available in 500-mg [...]
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. benicar 40 mg The FDA is adopting the Systematized Nomenclature of Medicine (SNOMED) as the standard computerized medical vocabulary system for coding important terms in [...]
Researchers at the University of Minnesota have found that daily doses of an experimental drug called nalmefene (Revex, BioTie Therapies, Finland), which has been used to treat alcoholism, may be able to reduce the urge to gamble. Nalmefene, an opioid antagonist, helps to take the compulsive thrill out of winning and losing by interfering with [...]
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 [...]
Venlafaxine (Effexor generic, Wyeth), an anti-depressant sometimes indicated for women with vasomotor symptoms of menopause, may lead to drug-induced hepatitis, warn pharmacists from the University of Iowa. A healthy 60-year-old woman developed hepatitis after taking venlafaxine 75 mg/day for one month. At her first visit, she had fever, cough, headache, and myalgia. An upper respiratory [...]
Tenofovir disoproxil fumarate (Viread, Gilead), an oral medication that inhibits retroviral replication, could have a new life as a convenient vaginal gel, say researchers from Harlem Hospital Center, Bronx-Lebanon Hospital/Center, University of Pennsylvania, and Miriam Hospital in Providence, Rhode Island. In the first phase 1 clinical trial to evaluate an antiretroviral agent as a vaginal [...]
