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Medications in Pregnancy & Lactation.Xlsx
Commonly Used Medications in Pregnancy and Lactation Breastfeeding Medications: Indication & Side Notes Comments Acne: Over the counter acne medications are low risk. Acne ● Benzoyl Peroxide products Acne Low risk Clindamycin topical Acne Low risk Erythromycin topical Acne Low risk *Finacea topical Acne Not recommended Proactiv Acne Low risk Salicylic Acid products Acne Low risk Allergies: Actifed (after 13 weeks) Nasal Congestion, Allergies Low risk Afrin Nasal Spray (only for 3 days) Nasal Congestion Low risk Low risk (may ↓ milk Alavert (Loratadine) Allergies supply) Low risk (may ↓ milk Benadryl (Diphenhydramine) Allergies & Nasal Congestion supply) Low risk (may ↓ milk Clarinex Allergies supply) Low risk (may ↓ milk Claritin (Loratadine) Allergies supply) Low risk (may ↓ milk Claritin D (after 13 weeks) Allergies & Nasal Congestion supply) Low risk (may ↓ milk Chlor-Trimeton Allergies supply) Flonase Rhinitis, Seasonal Allergies Low risk Phenylephrine (after 13 weeks) Nasal Congestion use caution Ocean’s Nasal Spray Allergies & Nasal Congestion Low risk Low risk (may ↓ milk Sudafed (Pseudoephedrine) (after 13 weeks) Nasal Congestion supply) Low risk (may ↓ milk Tavist (Clemastine) Allergies supply) ● Please Contact Your Pediatrician concerning use in breast feeding. * Prescription medications Low risk (may ↓ milk Zyrtec Allergies supply) Antibiotics: *Amoxicillin Infection Low risk *Ampicillin Infection Low risk *Augmentin Infection Low risk *Keflex (Cephalexin) Infection Low risk *Cefuroxime Infection Low risk *Duricef (Cefadroxil) -
No. 33981 2 No
Pretoria, 4 February 2011 Februarle No. 33981 2 No. 33981 GOVERNMENT GAZETTE, 4 FEBRUARY 2011 IMPORTANT NOTICE The Government Printing Works will not be held responsible for faxed documents not received due to errors on the fax machine or faxes received which are unclear or incomplete. Please be advised that an "OK" slip, received from a fax machine, will not be accepted as proof that documents were received by the GPW for printing. If documents are faxed to the GPW it will be the sender's respon sibility to phone and confirm that the documents were received in good order. Furthermore the Government Printing Works will also not be held responsible for cancellations and amendments which have not been done on original documents received from clients. CONTENTS INHOUD Bladsy Koerant Page Gazette No. No. No. No. No. No. GENERAL NOTICE ALGEMENEKENNISGEWING Health, Department of Gesondheld, Departement van General Notice A/gemene Kennisgewing 58 Medicines and Related Substances Act 58 Wet op Beheer van Medisyne en (101/1965): Medicines Control Council: Verwante Stowwe (101/1965): Conditions of registration of a medicine Medisynebeheerraad: Voorwaardes vir in terms of the provisions of section die registrasie van 'n medisyne in terme 15 (7) ..................................................... .. 3 33981 van die bepalings van artikel 15 (7) ........ 4 33981 STAATSKOERANT, 4 FEBRUARIE 2011 No. 33981 3 GENERAL NOTICE ALGEMENE KENNISGEWING NOTICE 58 OF 2011 MEDICINES CONTROL COUNCIL CONDITIONS OF REGISTRATION OF A MEDICINE IN TERMS OF THE PROVISIONS OF SECTION 15(7) OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT 101 OF 1965) 1. The applicant shall ensure that the medicine is manufactured and controlled in terms of the current Good Manufacturing Practices as determined by Council 2. -
IN the UNITED STATES DISTRICT COURT for the DISTRICT of DELAWARE ALZA CORPORATION and JANSSEN PHARMACEUTICALS, INC., Plaintiffs
Case 1:16-cv-00914-UNA Document 3 Filed 10/07/16 Page 1 of 20 PageID #: 24 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ALZA CORPORATION and ) JANSSEN PHARMACEUTICALS, INC., ) ) Plaintiffs, ) ) v. ) Civil Action No. ____________ ) REDACTED PUBLIC VERSION AMNEAL PHARMACEUTICALS OF ) NEW YORK, LLC and ) AMNEAL PHARMACEUTICALS LLC, ) ) Defendants. ) COMPLAINT In this patent infringement action, Plaintiffs ALZA Corporation ("ALZA") and Janssen Pharmaceuticals, Inc. (collectively "Plaintiffs"), for their complaint against Defendants Amneal Pharmaceuticals of New York, LLC ("Amneal Pharms. NY") and Amneal Pharmaceuticals LLC ("Amneal Pharms. LLC") (collectively, "Amneal"), allege as follows: NATURE OF THE ACTION 1. This is an action for patent infringement under the patent laws of the United States, Title 35, United States Code, in response to, inter alia, the submission by Amneal of Abbreviated New Drug Application ("ANDA") No. 207515, with the U.S. Food and Drug Administration ("FDA") seeking approval to manufacture and sell a generic version of CONCERTA® prior to the expiration of U.S. Patent No. 8,163,798 ("the '798 patent") and U.S. Patent No. 9,144,549 ("the '549 patent"). PARTIES 2. Plaintiff ALZA is a Delaware corporation, having its principal place of business at 700 Eubanks Drive, Vacaville, California 95688. Case 1:16-cv-00914-UNA Document 3 Filed 10/07/16 Page 2 of 20 PageID #: 25 REDACTED PUBLIC VERSION 3. Plaintiff Janssen Pharmaceuticals, Inc. ("Janssen") is a Pennsylvania corporation, having a place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey 08560. 4. On information and belief, Defendant Amneal Pharms. LLC is a limited liability company organized under the laws of the State of Delaware and has a place of business at 400 Crossing Boulevard, Bridgewater, NJ 08807. -
Management Team
Management Team Bruce C. Cozadd Executive Chairman Bruce Cozadd joined Jazz Pharmaceuticals at its inception. From 2001 until he joined Jazz Pharmaceuticals, Mr. Cozadd served as a consultant to companies in the biopharmaceutical industry. From 1991 until 2001, he held various positions with ALZA Corporation, a pharmaceutical company now owned by Johnson & Johnson, most recently as its Executive Vice President and Chief Operating Officer, with responsibility for research and development, manufacturing and sales and marketing. Previously at ALZA Corporation he held the roles of Chief Financial Officer and Vice President, Corporate Planning and Analysis. Mr. Cozadd received a B.S. from Yale University and an M.B.A. from the Stanford Graduate School of Business. Mr. Cozadd serves on the boards of Cerus Corporation, a biopharmaceutical company; Threshold Pharmaceuticals, a biotechnology company; and The Nueva School and Stanford Hospital and Clinics, both non-profit organizations. Samuel R. Saks, MD Chief Executive Officer Samuel Saks, M.D., joined Jazz Pharmaceuticals at its inception. From 2001 until he joined Jazz Pharmaceuticals, Dr. Saks was Company Group Chairman of ALZA Corporation and served as a member of the Johnson & Johnson Pharmaceutical Group Operating Committee. From 1992 until 2001, he held various positions with ALZA Corporation, most recently as its Chief Medical Officer and Group Vice President, where he was responsible for clinical and commercial activities. Dr. Saks received a B.S. and an M.D. from the University of Illinois. Dr. Saks serves on the board of Trubion Pharmaceuticals and Cougar Biotechnology. Robert M. Myers President Robert Myers joined Jazz Pharmaceuticals at its inception and was appointed as Jazz Pharmaceuticals’ President in March 2007. -
SAMHSA DTAB Minutes
Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Prevention (CSAP) Drug Testing Advisory Board June 11-12, 2019 Minutes – Open Session SAMHSA’s CSAP Drug Testing Advisory Board (DTAB) convened on June 11-12, 2019. In accordance with the provisions of Public Law 92-463, the meeting was open to the public from 9:30 a.m. to 4:30 p.m. A final presentation/discussion on Regulatory Program Requirements was scheduled for the open session on June 12, 2019 and is included herein. Table of Contents Board Members in Attendance ................................................................................................1 Call to Order ............................................................................................................................2 Welcome and Introductory Remarks ........................................................................................ 2 Department of Transportation (DOT) Update ........................................................................... 3 Nuclear Regulatory Commission 10 CFR Part 26 Fitness for Duty Program Update, .............. 5 Department of Defense Drug Testing Update .......................................................................... 7 Program Updates by DWP (Urine, Oral Fluid, and Hair Mandatory Guidelines) ....................... 8 Update on Emerging Marijuana Legalization ........................................................................... 9 Drug Testing Index (DTI) Data: -
Notice Under S66 of the Commerce Act 1986 Application by Johnson & Johnson to Acquire the Stock, Assets and Business Of
PUBLIC COPY Notice under s66 of the Commerce Act 1986 Application by Johnson & Johnson to acquire the stock, assets and business of the Consumer Healthcare division of Pfizer Inc. COMMERCE ACT 1986: BUSINESS ACQUISITION SECTION 66: NOTICE SEEKING CLEARANCE 28 September 2006 The Registrar Business Acquisitions and Authorisations Commerce Commission PO Box 2351 Wellington Pursuant to s66(1) of the Commerce Act 1986 notice is hereby given seeking clearance of a proposed business acquisition. 518689_1.DOC 2 CONTENTS EXECUTIVE SUMMARY PART 1: TRANSACTION DETAILS 1 The business acquisition for which clearance is sought 2 The person giving this notice 3 Confidentiality 4 Participants 5 Interconnected and associated persons 6 Beneficial interests 7 Links between participants 8 Common directorships 9 Business activities of the participants 10 Reasons for the proposed acquisition PART II: IDENTIFICATION OF MARKETS AFFECTED 11 Horizontal aggregation 12 Differentiated product markets 13 Differentiated product markets 14 Vertical integration 15 Other business acquisitions PARTS III, IV AND V: CONSTRAINTS ON MARKET POWERS BY EXISTING AND POTENTIAL COMPETITION AND OTHER POTENTIAL CONSTRAINTS 16 Allergy medication 17 Products for the treatment of worms 18 Thrush treatment CERTIFICATE APPENDICES 1. Heartburn and indigestion remedies (MYLANTA and MOTILIUM) 2. Worm treatments (COMBANTRIN, VERMOX) 3. Cold, flu, nasal decongestant, cough relief and sort throat medications (CODRAL, SINUTAB, SUDAFED, BENADRYL, BRONDECON) 4. Allergy relief products (ACTIFED, SINUTAB, SUDAFED, VISINE, LIVOSTIN) 518689_1.DOC 3 5. Thrush treatments (DIFLUCAN ONE, DAKTARIN, DAKTAGOLD, NIZORAL, SPORANOX) 6. Shampoo (PREGAINE, ROGAINE, NEUTROGENA, JOHNSON’S BABY SHAMPOO) 7. Hand hygiene (PURELL and MICRO SHIELD) 8. Competitor worm treatment products 9. Multinational pharmaceutical businesses: GlaxoSmithKline, Douglas Pharmaceuticals, Alphapharm, Bayer Group 10. -
Frequently Asked Questions
Frequently Asked Questions Why are these companies included on the "Do Test" list? The following companies manufacture products that are tested on animals at some stage of development. Those marked with a Ƈ are currently observing a moratorium on (i.e., current suspension of) animal testing. Please encourage them to announce a permanent ban. Listed in parentheses are examples of products manufactured by either the company listed or, if applicable, its parent company. For a complete listing of products manufactured by a company on this list, please visit the company's website or contact the company directly for more information. Companies on this list may manufacture individual lines of products that have not been tested on animals. They have not, however, eliminated tests on animals for their entire line of cosmetics and household products. What if a company isn't on either of PETA's lists? Some companies have refused to respond to specific questions about their testing practices. It appears likely that these companies do test on animals at some stage of product development, and their refusal to clarify their testing policies appears to be an attempt to mislead consumers. Other companies may be new. If you find a company not included on our lists, please share the company's contact information with PETA so that we can contact the company directly. Legend Ƈ The company is currently observing a moratorium on animal testing. 3M 3M Corporate 1-888-364-3577 www.solutions.3m.com Headquarters 3M Center St. Paul, Minnesota 55144-1000 Acuvue (Johnson & Johnson) Customer (800) 843-2020 www.acuvue.com/ Relations, D-QA 7500 Centurion Parkway Jacksonville, Florida 32256 Aim (Church & Dwight) P.O. -
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. -
Management Liability Focus Johnson & Johnson 1
Insured Profile Report – Management Liability Focus Johnson_________________________________________________________________________ & Johnson Company Profile Credit Details Location 1 Johnson and Johnson Plz Overall Credit Risk High Risk New Brunswick, NJ www.jnj.com Number of Legal Derogatory 84 Company Type Public Items Liability Amount $322,285.00 Formerly Known As N/A Experian Intelliscore 2.57 SIC Code 2834 SIC Code Description Pharmaceutical Preparations Experian Intelliscore Percentile 2.00 % of companies score lower and have higher credit risk Established 1955 Experian Commercial IntelliscoreSM is an all-industry commercial model using business information to predict business risk. Its Sales (in millions) $65,030.00 predictiveness is among the best on the market today The objective of the Commercial Intelliscore Model is to predict seriously Employees 117,900 derogatory payment behavior. Possible score range from 0 to 100, where 0 is high risk and 100 is low risk Total OSHA Violations 18 -Liability Amount is the total dollar amount of debtor’s legal liability, OSHA is an arm of the Department of Labor that conducts inspections of company including accounts in collection, tax liens,judgments and/or bankruptcies facilities with the goal of preventing work-related injuries, illnesses and deaths. -The Number of Legal Derogatory items are the sum of Tax-Lien Worksites that do not meet health and/or safety standards at the time of inspection may Count, Bankruptcy,Judgment, Collection-Counter and UCC Derog receive an OSHA violation. Total FDA NDC Drugs 177 The total number of FDA Drugs filed in the FDA NDC Drug Database. Business Description Johnson & Johnson is engaged in the research and development, manufacture and sale of a range of products in the healthcare field. -
Bengay® Greaseless Pain Relieving Cream Bengay® Ultra Strength
PATIENT PACKAGE INSERT IN ACCORDANCE 2. BEFORE USING THE MEDICINE: Directions for use: Apply a thin layer on the achy 5. HOW SHOULD THE MEDICINE BE WITH THE PHARMACISTS’ REGULATIONS area only and gently massage until the cream STORED? (PREPARATIONS) - 1986 Do not use this medicine: disappears )is absorbed(. • if you are sensitive )allergic( to the active • Avoid poisoning! This medicine and any other This medicine is dispensed ingredients or to any of the other ingredients Do not exceed the recommended dose. medicine must be kept in a safe place out of without a doctor’s prescription contained in the medicine. Do not swallow! For external use only. the reach of children and/or infants to avoid • If there is no improvement in your condition within poisoning. Do not induce vomiting without on damaged skin or on sores. explicit instruction from the doctor. ® • 10 days, refer to a doctor. in children and infants under 12 years of age, • Do not use the medicine after the expiry date BenGay Greaseless without a doctor’s instructions. If you took an overdose, or if a child accidentally swallowed the medicine, immediately refer to a )exp. date( that appears on the package. The Pain Relieving Cream Special warnings regarding use of the doctor or proceed to a hospital emergency room expiry date refers to the last day of that month. Cream medicine and bring the package of the medicine with you. • Store in a cool place between 20-25°C. • Excessive use may result in salicylate toxicity Do not take medicines in the dark! Check the • Store in the original package. -
Annual Report
ANNUAL REPORT 2019 MARCH 2020 To Our Shareholders Alex Gorsky Chairman and Chief Executive Officer By just about every measure, Johnson & These are some of the many financial and Johnson’s 133rd year was extraordinary. strategic achievements that were made possible by the commitment of our more than • We delivered strong operational revenue and 132,000 Johnson & Johnson colleagues, who adjusted operational earnings growth* that passionately lead the way in improving the health exceeded the financial performance goals we and well-being of people around the world. set for the Company at the start of 2019. • We again made record investments in research and development (R&D)—more than $11 billion across our Pharmaceutical, Medical Devices Propelled by our people, products, and and Consumer businesses—as we maintained a purpose, we look forward to the future relentless pursuit of innovation to develop vital with great confidence and optimism scientific breakthroughs. as we remain committed to leading • We proudly launched new transformational across the spectrum of healthcare. medicines for untreated and treatment-resistant diseases, while gaining approvals for new uses of many of our medicines already in the market. Through proactive leadership across our enterprise, we navigated a constant surge • We deployed approximately $7 billion, of unique and complex challenges, spanning primarily in transactions that fortify our dynamic global issues, shifting political commitment to digital surgery for a more climates, industry and competitive headwinds, personalized and elevated standard of and an ongoing litigious environment. healthcare, and that enhance our position in consumer skin health. As we have experienced for 133 years, we • And our teams around the world continued can be sure that 2020 will present a new set of working to address pressing public health opportunities and challenges. -
Caring for the World . . .One Person at a Time™ Inspires and Unites the People of Johnson & Johnson
OUR CARING TRANSFORMS 2007 Annual Report Caring for the world . .one person at a time™ inspires and unites the people of Johnson & Johnson. We embrace research and science—bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. The people in our more than 250 companies come to work each day inspired by their personal knowledge that their caring transforms people’s lives . one person at a time. On the following pages, we invite you to see for yourself. Our Caring Transforms ON THE COVER Johnson & Johnson is founding sponsor and continues to support Safe Kids Worldwide®. For 20 years the organization has grown, now teaching prevention as a way to save children’s lives in 17 countries around the world. In Brazil, Nayra Yara da Paz de Jesus carefully washes her hands, a safe, healthy habit she and other children are learning from a local Safe Kids® program. Find out more in our story on page 22. C H A I R M A N ’ S L E T T E R To Our Shareholders Caring for the health and well-being of people throughout the world is an extraordinary business. It is a business where people are passionate about their work, because it matters. It matters to their families, to their communities and to the world. It is a business filled with tremendous opportunity for leadership and growth in the 21st century; a business where unmet needs still abound and where people around the world WILLIAM C.