FDA NEWS

FDA Proposes New Drug Labels for Pregnant Women - WTVF
WEDNESDAY, May 28 (HealthDay News) -- U.S. health officials proposed Wednesday changes to the labels on prescription drugs that would detail potential health effects for pregnant and breast-feeding women, their fetuses or their newborns. If enacted
Source: www.newschannel5.com

FDA requests more info on Wyeth's pneumonia drug - Boston Globe
COLLEGEVILLE, Pa.— Wyeth said Thursday the Food and Drug Administration will require more information on the safety and effectiveness of its antibiotic Tygacil in treating community-acquired pneumonia before granting approval. Tygacil is currently
Source: www.boston.com

GS1 US and FMI to Unveil Powerful New Tool to Address Recall - Forbes
Recent product recalls worldwide have forced businesses to re-assess their current recall operating procedures and to look for new ways to improve existing recall efforts to ensure consumer safety. In response, GS1 US and the Food Marketing Institute
Source: www.forbes.com

UPDATE 1-Lilly sees approval soon for long-acting Zyprexa - Reuters
NEW YORK, May 29 (Reuters) - Eli Lilly and Co (LLY.N: Quote , Profile , Research ) said on Thursday a long-acting form of its schizophrenia drug Zyprexa will likely become available in the United States in the "near future," based on favorable
Source: www.reuters.com

Lilly sees approval soon for long-acting Zyprexa - Reuters
NEW YORK, May 29 (Reuters) - Eli Lilly and Co (LLY.N: Quote , Profile , Research ) said on Thursday the long-acting form of its schizophrenia drug Zyprexa will likely become available in the United States in the "near future," based on favorable
Source: www.reuters.com

Watson says Oxybutynin Topical Gel NDA accepted for filing by FDA - Forbes
CORONA, Calif. (Thomson Financial) - Watson Pharmaceuticals , Inc., a specialty pharmaceutical company, announced Wednesday that its New Drug Application (NDA) for oxybutynin chloride topical gel (OTG), has been accepted for filing by the U.S. Food
Source: www.forbes.com

FDA says Glaxo drug fails to control bleeding - Associated Press
WASHINGTON (AP) -- An experimental drug from GlaxoSmithKline does not significantly lower bleeding in patients with a rare blood disorder, according to the Food and Drug Administration. British drugmaker Glaxo is seeking approval for Promacta to
Source: hosted.ap.org

Wyeth gets fast track designation from FDA for investigational vaccine - Forbes
NEW YORK (Thomson Financial) - Wyeth's pharmaceutical unit Thursday said it received fast track designation from the Food and Drug Administration for its investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers. The company
Source: www.forbes.com

FDA requests more info on Wyeth's pneumonia drug - Forbes
Wyeth said Thursday the Food and Drug Administration will require more information on the safety and effectiveness of its antibiotic Tygacil in treating community-acquired pneumonia before granting approval. Tygacil is currently approved to treat
Source: www.forbes.com