Latest Fda Approved Drugs Information Systems

March 15, 2012 — An azithromycin-resistant variant of gonorrhea that developed in just 12 days was detected with genotyping and highlights the rapid emergence of clinical gonococcal resistance, according to a new report. Olusegun Soge, PhD, from the Neisseria Reference Laboratory at the University of Washington, in Seattle, reported the findings at the 2012 National STD Prevention Conference, held in Minneapolis, Minnesota. According to Dr. Soge and colleagues, the US Centers for Disease Control and Prevention (CDC) recommends dual therapy with ceftriaxone and azithromycin for the treatment of gonorrhea. "Although azithromycin has been effective for the treatment of gonorrhea, azithromycin monotherapy is not recommended because of concerns about rapid emergence of macrolide resistance," the authors write. The report describes the development of resistance to azithromycin in a 26-year-old man with gonococcal urethritis confirmed by culture. The patient received oral...

March 14, 2012 — The US Food and Drug Administration (FDA) today approved escitalopram tablets for the treatment of adults with depression and general anxiety disorder, making this the first generic version of Lexapro (Forest Pharmaceuticals) to receive FDA approval for treating both disorders. "These psychiatric conditions can be disabling and prevent a person from doing everyday activities," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a release. "This medication is widely used by people who must manage their condition over time, so it is important to have affordable treatment options," added Dr. Woodcock. Today's approval will allow Teva Pharmaceutical Industries/IVAX Pharmaceuticals to market the generic tablets in dosages of 5, 10, and 20 mg. In addition, the FDA granted a 180-day period of generic drug exclusivity to Teva. The most common treatment-related adverse effects reported in past studies...

March 9, 2012 — The US Food and Drug Administration (FDA) has issued a complete response letter for a supplemental new drug application proposing a label expansion of capsaicin 8% patch ( Qutenza , NeurogesX, Inc) to treatment of pain related to peripheral neuropathy in patients with HIV. The patch, a dermal delivery system containing 8% capsaicin, is the company’s lead product and was approved in 2009 in the United States and the European Union for the treatment of pain from postherpetic neuralgia. The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee almost unanimously  recommended against  granting the expanded indication for HIV-related peripheral neuropathy pain last month. The complete response letter from the FDA based on this vote was received by the company March 7. During the FDA panel meeting on February 9, the 12-member committee was asked to discuss the safety and efficacy of the patch and finally to vote on the question "based on the curren...

By Anna Yukhananov WASHINGTON (Reuters) Mar 09 - U.S. drug regulators are asking experts for advice on whether companies should restart clinical trials for painkillers that help people with osteoarthritis and other conditions, but can destroy joints. In a memo posted online Thursday The U.S. Food and Drug Administration said these drugs, from the class of anti-nerve growth factors, "represent a potentially significant and novel strategy for the treatment of pain." Nerve growth factor (NGF) is associated with nerve pain, but it may also help with wound repair and angiogenesis, the FDA said. The joint problems with the drug may be because it blocks these beneficial effects of NFG, one FDA reviewer said. In 2010, the FDA halted almost all clinical trials of NGF inhibitors after nearly 500 people taking the drugs in studies needed joint replacement. Companies were allowed to keep testing the drugs in terminal cancer patients with severe bone pain, since the benefits ...

March 13, 2012 — The US Food and Drug Administration (FDA) Arthritis Advisory Committee has unanimously agreed to let Janssen, Pfizer, and Regeneron resume clinical trials with their respective anti–nerve growth factor (NGF) drugs, despite cases of joint destruction and osteonecrosis associated with their use. The panel voted 21 yes, 0 no, with no abstentions, when asked whether the risk–benefit profile of the anti-NGF agents indicated a role for their ongoing development. The drugs are being developed for the treatment of a variety of chronic painful conditions, including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, postherpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain. Nerve growth factor promotes pain by inducing hyperalgesia in various disease states through various molecular mechanisms, resulting in sensitization of peripheral nociceptors, axonal sprouting, and se...

By Anna Yukhananov WASHINGTON (Reuters) Mar 08 - Prescription drugs to treat some of the most common chronic diseases, such as high cholesterol and diabetes, may become available over the counter under a plan being considered by U.S. regulators. In what would be a major shift in policy if finalized, the Food and Drug Administration is seeking public comment until Friday on a way to make these medications more readily available. It will also have a meeting about the proposal at the end of March. The goal is to ensure people take drugs as needed, while still understanding safety issues. Experts say the unwillingness of people to take certain medications as prescribed has undermined effective treatment of conditions including high blood pressure, raising the cost of healthcare in the United States. For example, the FDA said about a third of those with high blood pressure stop taking their medication. The problem with making these drugs available without a prescription is th...

April 19, 2012 — The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) have issued a joint position statement emphasizing patient-specific treatment of hyperglycemia in persons with type 2 diabetes. The  new guidelines are reported concurrently in the April 19 online edition of  Diabetes Care  and in  Diabetologia . "All guidelines are in a state of evolution based on new information, and the overall standard of care is updated every January," Vivian Fonseca, MD, ADA president of medicine and science, told  Medscape   Medical News  in a telephone interview. The last guidelines specific to management of hyperglycemia were published about 4-5 years ago, and more recent developments have been incorporated into the new guidelines." The impetus underlying the new guidelines was the growing complexity and controversy surrounding contemporary glycemic management in persons with type 2 diabetes. Factors ...