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Orange Book Cumulative Supplement 7 July 2006
CUMULATIVE SUPPLEMENT 07 July 2006 APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 26th EDITION Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Generic Drugs 2006 Prepared By Office of Generic Drugs Center for Drug Evaluation and Research Food and Drug Administration APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS 26th EDITION Cumulative Supplement 07 July 2006 CONTENTS PAGE 1.0 INTRODUCTION ........................................................................................................................................ iii 1.1 How to use the Cumulative Supplement ........................................................................................... iii 1.2 Applicant Name Changes.................................................................................................................. iv 1.3 Availability of the Edition ................................................................................................................... vi 1.4 Report of Counts for the Prescription Drug Product List ................................................................... vi 1.5 Zocor (simvastatin) Patent Relisting.................................................................................................viii 1.6 Cumulative Supplement Legend ....................................................................................................... vi DRUG PRODUCT LISTS Prescription Drug Product List ...................................................................................................... -
Audit Final Pn 5-28-04
Appendix Radio Radio Callsign Service Licensee State Callsign Service Licensee State KA26590 IG MDOI INC TX KA96512 IG PM REALTY GROUP TX KA2774 PW OXFORD, VILLAGE OF MI KAA245 IG YELLOW & CITY CAB CO KS KA3917 IG SCRANTON TIMES PA KAD598 PW RED OAK VETERINARY CLINIC IA KA40009 IG GADSDEN, CITY OF AL KAE933 IG FOODSERVICE MANAGEMENT GROUPFL INC KA40058 IG HOUMANN, JIM:HOUMANN, CHETND KAG551 PW COOK, RICHARD L MO KA42246 IG HOUSTON FLEA MARKET INC TX KAH411 IG MIKE HOPKINS DIST CO INC TX KA42563 IG MUIRFIELD VILLAGE GOLF CLUBOH KAH535 PW CEDAR RAPIDS, CITY OF IA KA4305 IG CITY OF LOS ANGELES DEPARTMENTCA OF KAJ418WATER & POWERIG KOPSA, LEO E IA KA43600 IG SHAPLEY, CHARLES P MO KAM394 IG CROOKSTON IMPLEMENT CO INCMN KA48204 PW PRESQUE ISLE, COUNTY OF MI KAM826 IG AIRGAS SOUTHWEST INC TX KA52811 IG R & R INDUSTRIES INC MA KAM951 IG TERRA INTERNATIONAL INC IA KA53323 IG ELK RIDGE LOG INC WA KAM983 IG RAY KREBSBACH & SONS IA KA53447 PW PIERCE, TOWNSHIP OF OH KAN247 IG BROCE CONSTRUCTION CO INCKS KA53918 IG B M I INC MI KAN892 PW HIAWATHA, CITY OF KS KA61058 IG THISTLE, RONALD F MA KAO274 IG MALINE, THOMAS G NE KA62473 PW KENTUCKY, COMMONWEALTH OFKY DBA KYKAP406 EMERGENCY MANAGEMENTIG DYNEGY IT INC TX KA64283 IG SAINT MARY MEDICAL CENTERWA KAP554 IG AWARE OPERATING SERVICES TXINC KA64769 IG SOUTHERN WAREHOUSING & DISTRIBUTIONFL KAQ533 LTD PW CALIFORNIA, STATE OF CA KA65089 IG DUN & BRADSTREET NJ KAQ708 PW PENNSYLVANIA, COMMONWEALTHPA OF KA65696 IG PARSONS INFRASTRUCTURE &CA TECHNOLOGYKAR785 GROUP PW PIMA, COUNTY OF AZ KA66353 IG BALTIMORE MARINE -
Oral Delivery Oct 06 18/1/07 20:19 Page 1
Oral Delivery Oct 06 18/1/07 20:19 Page 1 ORAL DRUG DELIVERY WHEN YOU FIND THE HOLY GRAIL www.ondrugdelivery.com Oral Delivery Oct 06 18/1/07 20:19 Page 2 “Oral drug delivery: when you find the Holy Grail” CONTENTS This edition is one in a series of sponsored themed publications from ONdrugDelivery Ltd. Each issue focuses on a specific topic within the field of drug delivery, and contain up to eight articles contributed Introductory comment by leaders in that field. Guy Furness 3 Full contact information appears alongside each article. Contributing companies would be delighted to hear Growing sales and new opportunities for oral from interested readers directly. ONdrugDelivery fast dissolve would also be very pleased to pass on to authors, or Dr Ian Muir answer as appropriate, any queries you might have in relation to this publication or others in the series. Cardinal Health 4-6 During 2007 ONdrugDelivery will be covering the following topics: From oral drug delivery technology to proprietary February: Transdermal delivery product development April: Pulmonary delivery Dr Anand Baichwal, Thomas Sciascia, MD June: Prefilled syringes Penwest Pharmaceuticals 7-10 August: Oral drug delivery October: Delivering injectables December: Nanotechnology in drug delivery Combination oral products: the time is now! Fred H. Miller To start a FREE subscription (pdf or print) to INNERCAP Technologies 12-15 ONdrugDelivery’s sponsored series, please contact ONdrugDelivery directly (details below) Combining technologies without compromise: taste masking + ODT + modified release Steve Ellul Eurand 16-19 Oral drug delivery: the Holy Grail To find out more about how your company can Ms Bavani Shankar participate in 2007, please contact ONdrugDelivery Emisphere Technologies 20-21 directly (details below). -
Federal Register/Vol. 77, No. 115/Thursday, June 14, 2012
Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices 35691 TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1, 2012, THROUGH MARCH 31, 2012—Continued PMA No., Docket No. Applicant Trade name Approval date P060008.S046, FDA–2012–M–0210 ... Boston Scientific Corp ......................... TAXUS Liberte´ Paclitaxel-Eluting Cor- February 22, 2012. onary Stent System (Monorail and Over-The-Wire Delivery Systems). P030025.S086, FDA–2012–M–0209 ... Boston Scientific Corp ......................... TAXUS Express2 Paclitaxel-Eluting February 22, 2012. Coronary Stent System (Monorail and Over-The-Wire Delivery Sys- tems). P110023, FDA–2012–M–0221 ............ ev3, Inc ................................................ Everflex Self-Expanding Peripheral March 7, 2012. Stent System (Everflex). P070004, FDA–2012–M–0250............ Sientra, Inc.......................................... SIENTRA Silicone Gel Breast Im- March 9, 2012. plants. II. Electronic Access LOCATION: The meeting will be held at submissions. In the process of Persons with access to the Internet the FDA White Oak Campus, 10903 considering these changes, FDA has may obtain the documents at http:// New Hampshire Ave., Bldg. 31 previously made available for comment www.fda.gov/MedicalDevices/ Conference Center, Great Room 1503, versions of documents that support ProductsandMedicalProcedures/ Silver Spring, MD 20993. The following making regulatory submissions in DeviceApprovalsandClearances/ link contains public meeting attendee electronic format using the (eCTD) information as well as frequently asked PMAApprovals/default.htm and http:// specifications. These draft documents questions and answers regarding public www.fda.gov/MedicalDevices/ represented FDA’s major updates to meetings at White Oak: http:// ProductsandMedicalProcedures/ Module 1 of the eCTD based on www.fda.gov/AboutFDA/ DeviceApprovalsandClearances/ previous comments. -
Memorandum JUL 1 6 201D
Memorandum Subject Date Additional Quota Letters Received by July 15, 2010 (DFN: 630-08.2) JUL 1 6 201D To From Christine A. Sanncrud. Ph.D., Chief "Barbar• J.Illoockholdt, Chief Drug & Chemical Evaluation Section Regul• torn Section Office of Diverison Control Off cL rl Diversion Control On July 15. 2010, this section received your e-mail requesting a review of seventeen (17) quota applications from sixteen (16) registered manufacturers to determine if there arc any pending administrative/legal actions against these applicants and to advise ODE of the findings. ODOR conducted reviews (NADDIS, CSA, etc), as well as surveyed the responsible field offices for their input and recommendations. Provided below are the results and recommendations. QUOTA APPLICANTS wan NO ADVERSE OR DEROGATORY INFORMATIO N Novartis Consumer I lealth Lincoln (10345) (b)(4);(b)(7)(E) Baxter (10346) Generics Bidco li bda Vintage (10347) Noramco Delaware (10348) Pharmaceuticals International inc. (10349) Pharmedium (10351) Pharmedium (10352) Rhodes (10356) Bio-Pharm (10357) Patheon (10358) Patheon (10359) Watson (10361) B & B (10363) lospira. Inc. NC (10364) Epic Pharma (10366) Mallinckrodt I lobart (10367) Chemtos (10368) Vol. II Page 55 2 Per consultation with the field offices. DEA does not have sufficient grounds to limit, restrict. or deny quota requests from these registrants. Based on this information. ODG suggests that you proceed with the completion of the quota applications. If you have any questions pertaining to this information. please feel free to contact me (b)(6);(b)(7)( or SC C) (b)(6);(b)(7)(C) Vol. II Page 56 Memorandum Subject Date Additional Quota Letters Received as of July 19, 201() (DFN: 630-08.2) stir 2 8 2010,., To Fr ,./"./ Christine A. -
Helen Keller Helen Keller
HELEN KELLER Prepared for USAID BHR/PVC GRANT NO. 3077 March 23, 1995 Contact Person: Louis D. Pizzarello, MD, MPH Medical Director Helen Keller International 90 Washington St. New York, NY 10006 A world leader ill blilldlless prer.:elllioIJ alld rehabilitotioll since 1915. WORLD HEADQUARTERS 90 WASHINGTO:-: STREET. NEW YORK, NEW YORK 10006 TEL (212) 943'()890 F.-\X (212) 943-1220 @ PROJECT SEE ANNUAL REPORT PROJECT SEE (Sustainable, Efficient, Eye Care) OCTOBER 1993-SEPTEMBER 1994 TABLE OF CONTENTS Executive Summary . • . • . • • . • . • . 1 I. Headquarters. • • . 3 ll. Mexico. • . • . • . .. 5 Ill. Morocco. • . • . • . • • . 11 IV. Philippines ....•..........•.......•...•...........•.•.. 18 V. Tanzania. ....... 25 Appendix I Childhood Blindness Technical Advisory Group (CBTAG) Forms and Guidelines Appendixll Procurement and Gifts-in-Kind per country Appendix III Headquarters and Field Organizational Charts Appendix IV Primary Eye Care Training Manual Draft Outline Appendix V Summary of Eye Disease Chihuahua State, Mexico Appendix VI Morocco Surgical Outcome Details Appendix VII Philippines Residency Training Map & Curriculum Appendix VIll 'fl Budget Pipeline October 1993-September 1994 •• PROJECrSEE ANNUAL REPORT OCTOBER 1993 - SEPTEMBER 1994 Executive Summm Project SEE ~ustainab1e, Efficient, Eye Care) is a major public health and blindness prevention effort undertaken by Helen Keller International. This project builds on progress attained through previous Matching Grant programs. Over the last year, Project SEE has successfully enhanced the ability of HKI field staff and Ministries of Health to deliver eye health and blindness prevention services to the people of Mexico, Morocco, Philippines and Tanzania. With the support of USAID and Helen Keller International, hundreds of thousands of families have access to services, not previously available to them, and in many cases, this service is now closer to home. -
Department of Vermont Health Access Over-The-Counter (OTC) Drugs
Department of Vermont Health Access Over-the-Counter (OTC) Drugs Report Date: 2/5/2020 DRUG CATEGORY BRAND / PA GENERIC DRUG DESCRIPTION NDC GENERI PRODUCT DESCRIPTION REQUIRED LABELER NAME C ACNE PRODUCTS Adapalene Gel 0.1% GALDERMA 00299491015 B DIFFERIN GEL 0.1% GALDERMA 00299491045 B DIFFERIN GEL 0.1% GALDERMA 00299492030 B DIFFERIN GEL 0.1% GALDERMA 00299492045 B DIFFERIN GEL 0.1% Benzoyl Peroxide Cloth 6% ACELLA PHARMACEUTICALS 42192016160 G BPO CLOTHS MIS 6% Benzoyl Peroxide Gel 10% RUGBY LABORATORIES 00536105656 G ACNE MEDICAT GEL 10% PERRIGO PHARMACEUTICALS 45802030801 G BENZOYL PER GEL 10% PERRIGO PHARMACEUTICALS 45802030896 G BENZOYL PER GEL 10% Benzoyl Peroxide Gel 2.5% PERRIGO PHARMACEUTICALS 45802010196 G BENZOYL PER GEL 2.5% Benzoyl Peroxide Gel 5% RUGBY LABORATORIES 00536105556 G ACNE MEDICAT GEL 5% PERRIGO PHARMACEUTICALS 45802021601 G BENZOYL PER GEL 5% PERRIGO PHARMACEUTICALS 45802021696 G BENZOYL PER GEL 5% Benzoyl Peroxide Liq 10% PERRIGO PHARMACEUTICALS 45802031801 G BENZOYL PER LIQ 10% WASH PERRIGO PHARMACEUTICALS 45802031834 G BENZOYL PER LIQ 10% WASH HARRIS PHARMACEUTICAL 67405083005 G BENZOYL PER LIQ 10% WASH HARRIS PHARMACEUTICAL 67405083008 G BENZOYL PER LIQ 10% WASH GLAXO CONSUMER HEALTHCARE L.P. 00145098505 G PANOXYL WASH LIQ 10% CROWN LABORATORIES 00316022855 G PANOXYL WASH LIQ 10% Benzoyl Peroxide Liq 4% CROWN LABORATORIES 00316022706 G PANOXYL WASH LIQ 4% GLAXO CONSUMER HEALTHCARE L.P. 00145266005 B PANOXYL-4 LIQ CREM WSH Benzoyl Peroxide Liq 5% PERRIGO PHARMACEUTICALS 45802028001 G BENZOYL PER LIQ 5% -
Pharmaceutical Research and Manufacturers of America – Phrma
The Short-Term and Long-Term Competitive Impact of Authorized Generics A Report for the Federal Trade Commission October 28, 2009 TABLE OF CONTENTS INTRODUCTION ........................................................................................................................... 1 DISCUSSION .................................................................................................................................. 3 I. LONG-TERM COMPETITIVE HARM IS UNLIKELY ................................................... 3 A. Unsupported Foreclosure Claims Have Been Made For Nearly Two Decades .................................................................................................................... 4 B. Marketplace Realities Undercut The Long-Tenn Foreclosure Theory .................... 7 1. Sales and Profitability Are Growing ........................................................... 7 2. Wall Street Valuations Are Growing ........................................................ 10 II. THE FTC PRICING ANALYSIS SHOWS $880 MILLION IN CONSUMER SAVINGS .......................................................................................................................... 14 III. CONSUMER SAVINGS SHOULD BE MEASURED USING WHOLESALE DATA AND WEIGHTED AVERAGE PRICES .............................................................. 17 A. The Wholesale Data Carries Far More Weight.. .................................................... 17 B. Average Drug Prices Should Be Volume-Weighted ............................................. 19 IV. -
Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Patent Drugs Under Patent Drugs Under Paten
Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under P Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under P Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under P Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patents Drugs Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under P Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Patent DrugsDrug Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Under Patent Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under P Drugs Under Patent Drugs Under Patent Drugs Under Patent Drugs Under -
Clinical Research Services
Clinical Research Services Advancing the future of medicine through research. Who We Are Experience Clinical Research Services is a department within Clinical Research Services has been involved CHI St. Alexius Health in Bismarck, ND. We are fully in clinical research since 1987. Our professional dedicated to providing research support services staff has more than 180 years of combined to physicians within our region and the valued experience in clinical trials. We are committed patients they serve. to providing outstanding service to ensure the success of every project. CHI St. Alexius Health is a tertiary care facility affiliated with PrimeCare, a health group which Our involvement in inpatient and outpatient combines the most experienced, trusted, and phase II-IV clinical and device research studies has proven medical leaders in the area. PrimeCare is contributed substantially to the approval of new comprised of a network which includes more than drugs and treatments. You should carefully consider 190 physicians in private and institutional practice, both the benefits and the risks of participation including: CHI St. Alexius Health, Mid Dakota Clinic, before enrolling in a study. The Bone & Joint Center, and other affiliated area physicians. Many of these physicians are actively Previous clinical study trials: involved as investigators for clinical trials. • Oncology • Orthopaedic • Rheumatology • Diabetes Our clinical research team is committed to providing: • Neurology • Weight loss • Rapid study start-up • Cardiology • Pain • Pro-active patient enrollment • Urology • Men’s Health • Clean data submission • Gastroenterology • Women’s Health • Highly experienced principal • Infectious Disease • Medical Devices investigators • Pediatric • Initial training and continuing education for all support personnel Sponsors Patient Demographics Abbott Laboratories Characteristics of our patients include Acorda Therapeutics, Inc. -
Dr. Richard Rozek
Dear Ms. Overstreet: I am interested in being considered for the vacancy on the Glynn Brunswick Memorial Hospital Authority. Per the instructions with the vacancy announcement, I attached a copy of my vita to the letter. I am an economist with a specialty in health care economics. I have worked on competition, regulation, contract, and tax issues in health care during my career in academic, federal government, and private sector positions. I have written articles on health care issues and testified in major health care litigations. I have owned a home on Jekyll Island since 1993. Please let me know if you need additional information. Sincerely, Richard P. Rozek, Ph.D. RICHARD P. ROZEK, PH.D. CONTACT INFORMATION Redacted Jekyll Island, GA 31527 Phone: 912 Redacted Redacted gmail.com BACKGROUND Dr. Rozek received a B.A. degree in Mathematics with honors from the College of St. Thomas, a M.A. degree in Mathematics from the University of Minnesota, and M.A. and Ph.D. degrees in Economics from the University of Iowa. Dr. Rozek began his professional career as an Assistant Professor at the University of Pittsburgh where he taught courses in industrial organization, mathematical economics, and microeconomic theory. Dr. Rozek then worked for over six years in the Bureau of Economics at the Federal Trade Commission in a series of senior staff positions including Deputy Assistant Director for Antitrust. While at the FTC, Dr. Rozek evaluated antitrust and regulatory issues in electric and gas utilities, oil pipelines, soft drinks, for-profit and nonprofit hospitals, motion pictures, pharmaceuticals, and information industries. -
ANNUAL REPORT 2007 Table of Contents
ANNUAL REPORT 2007 table of contents _____________________________________________________PAGE _____________________________________________________2 Dedication _____________________________________________________3 Message from the Chairman and the President & CEO _____________________________________________________4 Introduction _____________________________________________________6 Our Focus _____________________________________________________10 Strategic Partnerships _____________________________________________________14 Emergency Response _____________________________________________________20 Our Partners _____________________________________________________25 Introduction and Certifi cation of Financial Statements _____________________________________________________26 Financial Statements _____________________________________________________28 Notes to the Financials _____________________________________________________34 Our Investors PHOTO (opposite page): Randy Olson, courtesy of BD In the spring of 2007, Direct Relief and a team of volunteers from the medical technology company BD worked together to improve health care for mothers and children in an underserved region in Ghana. See page 11 for their story. This report is dedicated to Dr. John Ganda July 27, 1942 – January 14, 2007 For his life-long dedication to the health and welfare of the people of Sierra Leone and his passionate resolve at the helm of the Ndegbomei Development Organization through many years of civil war. 2 Message from the Chairman and the President