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May 21, 2007，The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled ...
Food and Drug Administration Approves First Generic Versions of Ambien (Zolpidem Tartrate) for the Treatment of Insomnia
Insomnia generic
2007/4/25
April 23, 2007，The U.S. Food and Drug Administration (FDA) today approved the first generic versions of Ambien (zolpidem tartrate) immediate-release tablets. Zolpidem (ZOLE-pi-dem) tartrate is a sedat...
Food and Drug Administration Announces Audio Broadcasts on Emerging Drug Safety Information
health care Audio Broadcasts
2007/4/23
April 20, 2007，The U.S. Food and Drug Administration (FDA) is alerting health care professionals and consumers to the availability of audio broadcasts that provide emerging drug safety information. Th...
US food and drug administration to Hold Public Hearing on Medication Guide Program
Medication Guide program pharmacies
2007/4/16
April 12, 2007，The Food and Drug Administration (FDA) will hold a public hearing on June 12 and 13, 2007, to obtain feedback on FDA’s Medication Guide program. Medication Guides are handouts given to ...
food and drug administration Announces that Companies Must Stop Marketing Suppository Products Containing Trimethobenzamide
Trimethobenzamide
2007/4/11
April 6, 2007,As part of the Food and Drug Administration's (FDA) on-going initiative to ensure that all marketed U.S. drugs have required marketing approval, the agency announced today that companies...
food and drug administration Announces Voluntary Withdrawal of Pergolide Products
Parkinson’s disease pergolide pharmacies
2007/3/30
March 29, 2007，The U.S. Food and Drug Administration (FDA) today announced that manufacturers of pergolide drug products, which are used to treat Parkinson’s disease, will voluntarily remove these dru...
food and drug administration Launches Web Page Warning Against Buying Accutane
isotretinoin antibiotics
2007/3/30
March 28, 2007，The U.S. Food & Drug Administration (FDA) is launching a special Web page to warn consumers about the dangers of buying isotretinoin (Accutane) online. Isotretinoin is a drug approved ...
food and drug administration Proposes New, Tougher Procedures for Membership on Advisory Committees
Drug food
2007/3/30
March 21, 2007，The U.S. Food and Drug Administration (FDA) today announced new draft guidance that would implement a more stringent approach for considering potential conflicts of interest for its adv...
food and drug administration Requests Label Change for All Sleep Disorder Drug Products
drugs Sleep Disorder
2007/3/30
March 14, 2007，The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen th...
food and drug administration Proposes to Strengthen Label Warning for Xolair
Label Warning Xolair asthma
2007/3/9
February 21, 2007，Today the Food and Drug Administration (FDA) announced that it has requested Genentech, Inc. add a boxed warning to the product label for omalizumab, marketed as Xolair. The boxed wa...
January 30, 2007，The U.S. Food and Drug Administration (FDA) today outlined a comprehensive commitment to the safety of drugs and other medical products. The FDA report, which also responds to a set o...
food and drug administration and VA to Share Information on the Safe Use of Medical Products
Medical Products biologics
2007/1/31
January 30, 2007，The U.S. Food and Drug Administration (FDA) in the U.S. Department of Health and Human Services and the Veterans Health Administration (VHA) in the U.S. Department of Veterans Affairs...
food and drug administration Proposes New Measures to Strengthen Drug Safety Under PDUFA Reauthorized User Fee Program
Drug Safety
2007/1/18
January 11, 2007，The Food and Drug Administration (FDA) today proposed recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program which, if adopted, would signi...
US food and drug administration Approves First Generic Ondansetron Tablets, Orally Disintegrating Tablets and Oral Solution
Ondansetron surgery radiotherapy cancer chemotherapy
2007/1/9
December 27, 2006,The Food and Drug Administration today approved the first generic versions of Zofran (Ondansetron) Tablets, Orally Disintegrating Tablets and Oral Solution which are indicated to pre...