« FDA Approvals - Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New | Main | H-E-B pulls stock of serrano peppers (The Orange Leader) H-E-B »

FDA Approvals - UCB Receives Not-Approvable Letter From FDA For Lacosamide For Diabetic


UCB Receives Not-Approvable Letter From FDA For Lacosamide For Diabetic Neuropathic Pain (Medical News Today)
UCB announced that it received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for lacosamide for the treatment of diabetic neuropathic pain in adults. The company will seek clarification from the FDA of its position and of the additional information required to obtain final marketing approval.

FDA Issues Not Approvable Letter For Iloperidone For The Treatment Of Schizophrenia To Vanda Pharmaceuticals (Medical News Today)
Titan Pharmaceuticals, Inc. (AMEX:TTP) announced that Vanda Pharmaceuticals, Inc. (NASDAQ:VNDA) has received a not approvable letter for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia, from the U.S. Food and Drug Administration (FDA). Vanda, the sub-licensee for iloperidone, is responsible for the development and commercialization of this product.

Salmonella Saintpaul Found On Mexican Farm Says FDA (Medical News Today)
US Food and Drug Administration (FDA) officials said on Wednesday that a sample of serrano pepper and a sample of irrigation water taken from a farm in Mexico contained Salmonella saintpaul with the same genetic fingerprint as the strain in the outbreak that started over 3 months ago and has sickened more than 1,300 people throughout the United States and parts of Canada.
 

©2006 FDA-News.com. All rights reserved.