Dockets Entered On November 24, 2003

Dockets Management



	Dockets Entered On November 24, 2003 Table of Contents



	Docket #			Title

	1981N-0033P			Antiplaque & Antiplaque-Related Claims

	1997S-0162			30-Day Structure Function Claim Notification Letters Dietary

	2000E-1403			Patent Extension Prevnair, No. 5,360,897

	2000E-1404			Patent Extension Levulan Kerastick, No. 5,079,262

	2001E-0030			Patent Extension for TEQUIN, No. 4,980,470

	2001E-0031			Patent Extension for EXELON, No. 4,948,807

	2001E-0098			TNKase, Patent Extension Application No.5,385,732

	2001E-0225			Patent Term Extension Application, CANCIDAS No. 5,514,650

	2001E-0367			Patent Term Extension Application, STARLIX No. 34,878

	2001E-0403			Patent Term Extension Application; Valcyte No. 6,083,953

	2001E-0419			Patent Term Extension Application, Precedex No. 4,910,214

	2002E-0020			Patent Term Application for Zometa No. 4,939,130

	2002E-0021			Patent Term Application for Hyperion LTK Sys. No. 4,976,709

	2002E-0064			Patent Extension Application for Tracleer, No. 5,292,740

	2002E-0147			Patent Extension 5,258,494, OP-1 Implant

	2002E-0150			Gynecare Intergel, U.S. Patent Extension No. 5,532,221

	2002E-0343			Patent Term Application for Zevalin No. 5,776,456

	2002E-0345			Patent Term Application for Aromanis No. 4,808,616

	2002N-0209			Governing First Amendment Case Law

	2002P-0406			ANDA Suitability for Amoxicillin & Clavulanate Potassium

	2002V-0415			LAD-01 Medical Laser Product

	2003D-0478			Guidance on Marketed Unapproved Drugs Compliance Policy Guide

	2003E-0030			Patent Term Extension Application for FASLODEX No. 4,659,516

	2003E-0031			Patent Extension Application for VFEND No. 5,567,817

	2003E-0032			Patent Term Extension Application for IMAGENT, No. 5,639,443

	2003E-0035			Patent Term Extension Application for ZETIA No. RE37,721

	2003E-0247			Patent Extension for Campath (Alemtuzumab), 5,545,403

	2003E-0249			Patent Extension for Elitek (rasburicase) 5,382,518

	2003E-0251			Patent 5,667,787, Daptacel (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine)

	2003E-0257			Patent Extension for Neotame, 5,480,668

	2003E-0260			Patent Extension for Amevive (alefacept), 5,547,853

	2003E-0405			Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080

	2003E-0406			Patent Term Restoration Application for Fabrazime, U.S. Patent No. 5,356,804

	2003E-0411			Patent Term Restoration Application for Facitive (gemifloxacin mesylate), U.S. Patent No. 5,633, 262

	2003E-0416			Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353

	2003E-0418			Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147

	2003E-0419			Iprivask, Patent Term Extension Application; U.S. Patent No. 4,745,177



2003E-0448	Patent Extension for FACTIVE, gemifloxacin mesylate, #5,776,944

2003E-0449	Patent Extension for FACTIVE, gemifloxacin mesylate, #5,962,468

2003E-0452	Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234

2003E-0458	Patent Extension, Velcade, bortezomib, #5,780,454

2003M-0532	Premarket Approval P000028 - AFFINITY Cage System

2003M-0533	P990027/S006 - Bausch & Lomb TECHNOLAS 217z Zyoptix System for Personalized Vision Correction

2003M-0536	HDE Number: H020003, CONTEGRA Pulmonary Valved Conduit

2003N-0312	Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds

2003N-0338	Obesity

2003N-0344	Consumer-Directed Promotion; Public Meeting

2003N-0361	Anti-Counterfeit Drug Initiative

2003N-0400	Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals

2003P-0270	Prohibit False and Misleading Labeling

2003P-0300	Cataflam (diclofenac potassium) Tablets 25 mg (NDA 20-142 voluntarily withdrawn or wtihheld from sale for safety or effectiveness reasons

1981N-0033P	Antiplaque & Antiplaque-Related Claims
C 12	Ciba Speciality Chemicals Corporation (Ciba)	Vol #:	19

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

LET 11559	Neways International	Vol #:	91

LET 11560	SmartScience Laboratories, Inc.	Vol #:	91

LET 11561	Enzymatic Therapy Natural Medicines	Vol #:	91

LET 11562	Reliance Vitamin Company, Inc.	Vol #:	91

LET 11563	Nutriment Innovations Inc.	Vol #:	91

LET 11564	Traditional Medicinals, Inc.	Vol #:	91

LET 11565	E'Ola International	Vol #:	91

LET 11566	Bio-Genics, Inc.	Vol #:	91

LET 11567	Bio-Genics, Inc.	Vol #:	91

LET 11568	Market America, Inc.	Vol #:	91

LET 11569	Naturade Inc.	Vol #:	91

LET 11570	Naturade Inc.	Vol #:	91

LET 11571	Naturade Inc.	Vol #:	91

LET 11572	Naturade, Inc.	Vol #:	91

LET 11573	Food Science of Vermont	Vol #:	91

LET 11574	Hansen's Natural	Vol #:	91

LET 11575	Enzymatic Therapy Natural Medicines	Vol #:	91

LET 11576	Enzymatic Therapy Natural Medicines	Vol #:	91



LET 11577	Enzymatic Therapy Natural Medicines	Vol #:	91

LET 11578	Enzymatic Therapy Natural Medicines	Vol #:	91

LET 11579	Phyto Pharmica Natural Medicines	Vol #:	91

LET 11580	Phyto Pharmica Natural Medicines	Vol #:	91

LET 11581	Phyto Pharmica Natural Medicines	Vol #:	91

LET 11582	Synergy Worldwide	Vol #:	91

LET 11583	Enzymatic Therapy Natural Medicines	Vol #:	91

LET 11584	Nature's Sunshine Products,Inc.	Vol #:	91

LET 11585	Enzymatic Therapy Natural Medicines	Vol #:	91

LET 11586	Enzymatic Therapy Natural Medicines	Vol #:	91

LET 11587	Source Naturals	Vol #:	91

LET 11588	Enzymatic Therapy Natural Medicines	Vol #:	91

LET 11589	Your Vitamins	Vol #:	91

2000E-1403	Patent Extension Prevnair, No. 5,360,897

LET 7	HFD-5 to US Patent & Trademark Office	Vol #:	1

2000E-1404	Patent Extension Levulan Kerastick, No. 5,079,262

LET 4	HFD-005 to US Patent & Trademark Office	Vol #:	1

2001E-0030	Patent Extension for TEQUIN, No. 4,980,470

LET 4	HFD-005 to US Patent & Trademark Office	Vol #:	1

2001E-0031	Patent Extension for EXELON, No. 4,948,807

LET 4	HFD-005 to US Patent & Trademark Office	Vol #:	1

2001E-0098	TNKase, Patent Extension Application No.5,385,732
LET 4	HFD-005 to US Patent & Trademark Office	Vol #:	1

2001E-0225	Patent Term Extension Application, CANCIDAS No. 5,514,650

LET 4	HFD-005 to US Patent & Trademark Office	Vol #:	1

2001E-0367	Patent Term Extension Application, STARLIX No. 34,878

LET 5	HFD-005 to US Patent & Trademark Office	Vol #:	1

2001E-0403	Patent Term Extension Application; Valcyte No. 6,083,953

LET 4	HFD-005 to US Patent & Trademark Office	Vol #:	1

2001E-0419	Patent Term Extension Application, Precedex No. 4,910,214

LET 3	HFD-005 to US Patent & Trademark Office	Vol #:	1



2002E-0020	Patent Term Application for Zometa No. 4,939,130

LET 4	HFD-005 to US Patent & Trademark Office	Vol #:	1

2002E-0021	Patent Term Application for Hyperion LTK Sys. No. 4,976,709

LET 4	HFD-005 to US Patent & Trademark Office	Vol #:	1

2002E-0064	Patent Extension Application for Tracleer, No. 5,292,740

LET 2	HFD-005 to US Patent & Trademark Office	Vol #:	1

2002E-0147	Patent Extension 5,258,494, OP-1 Implant

LET 3	HFD-005 to US Patent & Trademark Office	Vol #:	1

2002E-0150	Gynecare Intergel, U.S. Patent Extension No. 5,532,221

LET 4	HFD-005 to US Patent & Trademark Office	Vol #:	1

2002E-0343	Patent Term Application for Zevalin No. 5,776,456

LET 3	HFD-005 to US Patent & Trademark Office	Vol #:	1

2002E-0345	Patent Term Application for Aromanis No. 4,808,616

LET 4	HFD-005 to US Patent & Trademark Office	Vol #:	1

2002N-0209	Governing First Amendment Case Law

C 112	Citrus Grower Associates, Inc. (CGA)	Vol #:	26

2002P-0406	ANDA Suitability for Amoxicillin & Clavulanate Potassium

C 2	The Weinberg Group, Inc.	Vol #:	2

2002V-0415	LAD-01 Medical Laser Product

SUP 1 Tab 2, 3	Norwood Abbey Ltd	Vol #:	1

2003D-0478	Guidance on Marketed Unapproved Drugs Compliance Policy Guide

EXT 1	Branded Pharmaceutical Assn (BPA)	Vol #:	1

2003E-0030	Patent Term Extension Application for FASLODEX No. 4,659,516

LET 3	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0031	Patent Extension Application for VFEND No. 5,567,817

LET 3	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0032	Patent Term Extension Application for IMAGENT, No. 5,639,443

LET 3	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0035	Patent Term Extension Application for ZETIA No. RE37,721



LET 3	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0247	Patent Extension for Campath (Alemtuzumab), 5,545,403

LET 2	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0249	Patent Extension for Elitek (rasburicase) 5,382,518

LET 2	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0251	Patent 5,667,787, Daptacel (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine)

LET 2	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0257	Patent Extension for Neotame, 5,480,668

LET 3	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0260	Patent Extension for Amevive (alefacept), 5,547,853

LET 2	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0405	Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080

LET 2	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0406	Patent Term Restoration Application for Fabrazime, U.S. Patent No. 5,356,804

LET 2	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0411	Patent Term Restoration Application for Facitive (gemifloxacin mesylate), U.S. Patent No. 5,633, 262

LET 2	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0416	Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353

LET 2	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0418	Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147

LET 2	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0419	Iprivask, Patent Term Extension Application; U.S. Patent No. 4,745,177

LET 2	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0448	Patent Extension for FACTIVE, gemifloxacin mesylate, #5,776,944

LET 2	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0449	Patent Extension for FACTIVE, gemifloxacin mesylate, #5,962,468

LET 2	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0452	Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234



LET 3	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003E-0458	Patent Extension, Velcade, bortezomib, #5,780,454

LET 2	HFD-005 to US Patent & Trademark Office	Vol #:	1

2003M-0532	Premarket Approval P000028 - AFFINITY Cage System

AAV 1	Medtronic Sofamor Danek	Vol #:	1

2003M-0533	P990027/S006 - Bausch & Lomb TECHNOLAS 217z Zyoptix System for Personalized Vision Correction

AAV 1 Approval Order, SSED, Labeling	Bausch & Lomb, Inc.	Vol #:	1

2003M-0536	HDE Number: H020003, CONTEGRA Pulmonary Valved Conduit

AAV 1 Approval Order, SSED, Labeling	Medtronic, Inc.	Vol #:	1

2003N-0312	Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds

C 6	South Dakota Department of Agriculture	Vol #:	1

2003N-0338	Obesity

C 8	National Restaurant Assn	Vol #:	6

2003N-0344	Consumer-Directed Promotion; Public Meeting

C 1 Tab 1, 2, 3, 4	Catalina Health Resource (CHR)	Vol #:	2

2003N-0361	Anti-Counterfeit Drug Initiative

C 40	University of Maryland	Vol #:	5

C 41	Pfizer, Inc. (Pfizer)	Vol #:	5

2003N-0400	Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals

C 15	Jill M. Korsmo	Vol #:	3

C 16	Honorable Dan Burton	Vol #:	3

C 17	Janet Girard	Vol #:	3

2003P-0270	Prohibit False and Misleading Labeling

C 42	Barbara Bear	Vol #:	6

2003P-0300	Cataflam (diclofenac potassium) Tablets 25 mg (NDA 20-142 voluntarily withdrawn or wtihheld from sale for safety or effectiveness reasons

LET 1	HFD-007 to The Weinberg Group, Inc.	Vol #:	1

Page Created November 25, 2003 dp
Page updated December 24, 2003

FDA/Dockets Management