Archive for July, 2009

FDA issues warning on Libipower

CialisFDA has issued a warning about Libipower Plus, which contains untested versions of a powerful prescription medication used to treat impotence in men. The manufacturer of this dangerous product Haloteco, have issued an immediate complete recall of Libipower Plus. The FDA has tested the product in their own laboratories and found it to contain a version of the active ingredient of the erectile dysfunction drug Cialis.

EOquin granted fast-track designation for bladder cancer

US health regulators have granted fast-track designation to Spectrum Pharmaceuticals Inc’s EOquin (apaziquone) drug candidate. EOquin is the experimental treatment for bladder cancer that has not that has not yet spread deep into the muscle layer. The non-muscle invasive type of bladder cancer accounts for 70% of the new diagnoses and said it affects more than a million patients in the US and Europe. Fast-track designation is designed to expedite the review of drugs to treat serious diseases and fill unmet medical needs.

Novadaq receives 510 clearance

Novadaq Technologies Inc, a developer of real-time imaging systems used in the operating room, announced that its SPY endoscopic imaging system has received 510(k) clearance from the US Food and Drug Administration for use during minimally invasive surgery (MIS). Novadaq’s SPY “scope” combines the traditional features of a state of the art, high definition standard endoscope with the fluorescence capabilities of the SPY imaging system, which is currently used in a variety of open surgical procedures.

P&G launches Asacol HD

Procter & Gamble Pharmaceuticals has launched Asacol HD (mesalamine) delayed-release tablets for the treatment of moderately active ulcerative colitis (UC), a form of inflammatory bowel disease. UC involves inflammation of the lining of the colon and rectum and is typically characterized by flares followed by periods of remission. Asacol HD 4.8 g/day 800 mg tablet was approved by the US FDA.

Urine test being developed for detecting lung cancer

Researchers at the University of Minnesota are closer to developing a simple urine test to identify smokers who are at high risk of developing lung cancer. Although the test is still years away, the hope is to spot high-risk people earlier when there is still time to prevent or treat the cancer, says Jian-Min Yuan, MD, associate professor of cancer epidemiology at the University.