Latest Drug safety Stories

New York owner had multiple violations of FDA veterinary drug regulations SILVER SPRING, Md., Nov. 1, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration (FDA) today announced that Raymond L. Martin, a sole proprietor operating Corner View Dairies, located in Lyons, NY, has signed a consent decree of permanent injunction. The decree prohibits Mr. Martin from selling animals with illegal levels of animal drugs and from administering drugs to animals without proper...

PISCATAWAY, N.J., Oct. 25, 2011 /PRNewswire/ -- INNOPHARMA LLC announced today FDA approval of its Abbreviated New Drug Application (ANDA) for olanzapine injection (the generic equivalent of Zyprexa® injection). As the developer of this generic injectable drug, INNOPHARMA entered into an agreement with Sandoz Inc., pursuant to which Sandoz will sell, market and distribute the product in the United States. About INNOPHARMA: INNOPHARMA is a sterile product development company, focused...

MOUNTAIN VIEW, Calif., Oct. 24, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the U.S. Food & Drug Administration (FDA) has scheduled a meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) for December 12, 2011, at which the ADASUVE New Drug Application (NDA) will be discussed. In August 2011, Alexza received notification that the FDA had accepted the resubmission of the ADASUVE NDA and assigned a Prescription Drug User Fee Act...

National Law Practice, Gold Law Firm, LLC. files many Flu Vaccine Injury Cases under the National Vaccine Injury Compensation Program. Many are not aware of Compensation Program and the deadlines that must be met in order to qualify. Wellesley Hills, MA (PRWEB) October 07, 2011 People cannot walk into their local Pharmacy or read their local paper without being bombarded with opportunities to take the Flu Vaccine. "This 'Flu Shot time of year' has led to an increase in the injuries and...

MELBOURNE, Australia, Sept. 30, 2011 /PRNewswire/ -- Circadian Technologies Limited (ASX: CIR, OTCQX:CKDXY) is extremely proud to announce that its 100% owned subsidiary, Vegenics Pty Ltd, has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate clinical studies of VGX-100. The first trial (Phase I) will involve the treatment of a variety of different cancer types in patients with late stage cancer. VGX-100 is a human antibody...

TUCSON, Ariz., Sept. 20, 2011 /PRNewswire-USNewswire/ -- As opponents of Michele Bachmann try to bully her into backing down on the HPV vaccine, one essential question is not being addressed, states the Association of American Physicians and Surgeons (AAPS). Are recipients of the HPV vaccine giving fully informed consent? "Simply giving patients a way to opt out is not enough," stated AAPS executive director Jane M. Orient, M.D. "Consent by patients should only occur after they have been...

FDA, Industry and USP Identify Current Gaps and Needs, Map Paths Forward to Help Ensure Public Health, Support Innovation Rockville, Md. (PRWEB) September 13, 2011 Top officials from the U.S. Food and Drug Administration (FDA), the pharmaceutical industry and the U.S. Pharmacopeial Convention (USP) expressed the need for modern scientific standards to help ensure the quality of over-the-counter (OTC) monograph medicines and their ingredients at a workshop, September 8-9. Widely relied...

BRUSSELS, September 9, 2011 /PRNewswire/ -- The Board of the European Fine Chemicals Group (EFCG) is delighted to announce that today it agreed to ratify the proposal of the US Food and Drug Administration (FDA) to put forward a legislative package, designed with the help of EFCG and US industry representatives, to deliver into US law a new Generic Drug User Fees Act (GDUFA). GDUFA requires the FDA to commit to significantly improve and enhance its regulatory activities...

Many cases of adverse drug reactions (ADRs) seen in hospital and emergency care could be prevented, says a new study to be presented to the annual conference of the International Pharmaceutical federation (FIP) tomorrow (Thursday) . The researchers who carried out the study say that the finding that preventable ADRs are so widespread has important implications for healthcare systems. Pharmacist Katja Hakkarainen, from the Nordic School of Public Health, Gothenburg, Sweden, and colleagues...

CHICAGO, Sept. 1, 2011 /PRNewswire/ -- Vikes, Dance Fever, French Fries. The names might not be familiar to you, but chances are good your kids have heard of them. These are the street names for prescription drugs, and more and more teens are using them to get high. To view the multimedia assets associated with this release, please click: http://multivu.prnewswire.com/mnr/besmartbewell/50821/ (Logo: http://photos.prnewswire.com/prnh/20110901/MM60576LOGO) Each year, nearly 2 million teens...