Lopid Patent Term Restoration and Fairness Act of 1987: Hearing Before the Subcommittee on Courts, Civil Liberties, and the Administration of Justice of the Committee on the Judiciary, House of Representatives, One Hundredth Congress, First Session, October 8, 1987, Volume 4U.S. Government Printing Office, 1988 - 350 pages |
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Page 19
... initial appli- cation was for the use of Lopid for lowering blood cholesterol and triglycerides . In our review of the clinical studies , we concluded that our general requirements for demonstrating an effect in re- ducing triglycerides ...
... initial appli- cation was for the use of Lopid for lowering blood cholesterol and triglycerides . In our review of the clinical studies , we concluded that our general requirements for demonstrating an effect in re- ducing triglycerides ...
Page 37
... initial reading , that seems contrary to your statement that it was FDA policy to require all sponsors who sought cholesterol - lowering claims to conduct post - approval studies . Or am I misinterpreting that ? Dr. YOUNG . It is a very ...
... initial reading , that seems contrary to your statement that it was FDA policy to require all sponsors who sought cholesterol - lowering claims to conduct post - approval studies . Or am I misinterpreting that ? Dr. YOUNG . It is a very ...
Page 40
... initial approved application , the pancreatitis application of this drug ? Or was it required because of the lifetime use that you just described of the second indication for which Warner - Lambert sought approval ? Dr. YOUNG . To the ...
... initial approved application , the pancreatitis application of this drug ? Or was it required because of the lifetime use that you just described of the second indication for which Warner - Lambert sought approval ? Dr. YOUNG . To the ...
Page 52
... initial data trends are highly encouraging . We believe the Helsinki Study will take its place alongside such epic works as the Framingham , World Health Organization and the National Heart , Lung , and Blood Institute studies . As ...
... initial data trends are highly encouraging . We believe the Helsinki Study will take its place alongside such epic works as the Framingham , World Health Organization and the National Heart , Lung , and Blood Institute studies . As ...
Page 59
... initial data trends have been highly favorable and that the Company remains convinced that the Helsinki Heart Study will ultimately demonstrate statistical significance for Lopid in the reduction of heart attacks . Further , the ...
... initial data trends have been highly favorable and that the Company remains convinced that the Helsinki Heart Study will ultimately demonstrate statistical significance for Lopid in the reduction of heart attacks . Further , the ...
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Common terms and phrases
apolipoprotein Association atherosclerosis baseline bill blood Capsules cardiovascular cent Chairman changes cholesterol cholesterol levels cholestyramine clofibrate Committee concentrations coronary heart disease decrease diabetic diet dose Drug Administration dyslipidaemic effect of gemfibrozil elevated fatty acid composition FDA approval Finland follow-up Food and Drug Framingham gemfibrozil treatment glucose HDL-cholesterol Health heart attacks Helsinki Heart Study hypercholesterolaemia hypertension incidence increase ischaemic heart disease Journal KASTENMEIER Kaukola laboratory legislation lipid lowering Lipid Research Clinics lipid-lowering lipoprotein cholesterol lipoprotein lipase lipoprotein lipase activity Lithell long-term Lopid Lopid patent low density lipoprotein LRC-CPPT male Manninen market exclusivity metabolism mmol/l mortality myocardial infarction Parke-Davis patent extension patent term extension patients pharmaceutical Phase IV study placebo Primary Prevention Trial ratio reduction regulatory risk factors Royal Society safety serum cholesterol serum lipid significant Society of Medicine Subcommittee Table Term Restoration Act therapy treatment groups triglycerides Vessby VLDL Warner-Lambert Waxman-Hatch
Popular passages
Page 113 - A simplified method for the estimation of total cholesterol in serum and demonstration of its specificity, J.
Page 113 - Lipid Research Clinics Program. The Lipid Research Clinics Coronary Primary Prevention Trial Results, II: the relationship of reduction in incidence of coronary heart disease to cholesterol lowering.
Page 291 - Kagan A.: Serum lipoproteins and coronary heart disease in a population study of Hawaii Japanese men.
Page 73 - I am a partner in the Washington, DC law firm of Covington & Burling. I have been asked to present testimony on patent term restoration.
Page 341 - Five-year findings of the Hypertension Detection and Followup Program. I. Reduction in mortality of persons with high blood pressure, including mild hypertension.
Page 244 - For the purposes of paragraph (2)(B), the term "due diligence" means that degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period.
Page 67 - HL-07182 from the National Heart, Lung and Blood Institute of the National Institutes of Health, and by the American Heart Association, Indiana Affiliate, Inc.
Page 8 - Mr. BOUCHER. Thank you very much, Mr. Chairman. I want to commend you...