DOCSLIB.ORG

Annual Report: 2017

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Annual Report: 2017 ANNUAL REPORT 2017 MARCH 2018 TO OUR SHAREHOLDERS ALEX GORSKY Chairman and Chief Executive Officer It is my honor to be writing my sixth the very edge of imagination and possibility. EVERY YEAR annual letter to you as shareholders That’s exciting, of course, and just a little FOR THE PAST 132 and stakeholders of this great company. daunting at the same time. Getting to that YEARS, JOHNSON Sometimes it seems as if these six years future will require urgency, boldness and & JOHNSON HAS have flown by in six minutes, given the fast vision—characteristics most often attributed BEEN INVOLVED pace of the world in which we all live and to very successful startups. However, I IN DEFINING work. Change is the dominant theme of believe it is also a great description of this THE FUTURE OF business, politics and culture today. company today—a 132 year-old startup. HEALTHCARE. During this time of unparalleled change, We are moving in fast-forward, but our it is vital that we do not become fixated momentum comes from a base as solid as on this very moment; but rather take a the marble on which Our Credo is inscribed. longer-term view and look much further It is our rock, our foundation, our DNA. Our ahead. In fact, every year for the past Credo was written seventy-five years ago, it 132 years, Johnson & Johnson has been remains relevant today, and I’m certain it will involved in defining the future of healthcare. continue to sustain us for the next seventy- No matter how many billions of lives we five years and beyond. have touched over those decades, or will touch in the years to come, we always see DELIVERING SHAREHOLDER and feel this challenge in the context of that VALUE one person, that one individual who has put Johnson & Johnson’s total shareholder their trust in us today and will tomorrow. return for 2017 was more than 24%, exceeding our competitor composite, Ahead, we see a future that lies beyond as well as exceeding most major indices the intersection of science and technology. which, I am proud to say, Johnson & We are rocketing toward that future, toward Johnson has done over the last three-, $)"*3."/µ4-&55&3 * five-, ten- and twenty-year periods. Our underscore our commitment to lead the shareholder return for 2017 is indicative of next frontier of health. the strength of our business, as well as the long-term strategic focus and execution A culture of collaborative innovation has that our leaders and teams have delivered been the basis for every achievement, every over the past several years. step and leap forward since our inception as a company. That culture—singularly Our track record of strong shareholder focused on the best outcomes for patients returns is also the result of our approach to and consumers around the world— managing for the long-term, our relentless continues to motivate us today. That’s why drive for innovation, our disciplined portfolio we are convinced that technology will A CULTURE OF management, our capital allocation strategy, not replace, but rather will extend human COLLABORATIVE and our unwavering commitment to the caring, that human touch which has always INNOVATION HAS highest level of execution, all of which are distinguished our work, and always will. BEEN THE BASIS regularly discussed as part of our ongoing FOR EVERY strategic planning with our Board of As the healthcare landscape, science and ACHIEVEMENT, Directors. technology continue to evolve, all three of EVERY STEP AND our business segments are well positioned LEAP FORWARD Most importantly, our success for to meet the needs of our patients, SINCE OUR shareholders reflects our singular focus consumers, healthcare professionals, INCEPTION AS on serving our patients and consumers, employees, communities and shareholders. A COMPANY. the doctors and nurses, the mothers and As with any organization, we have areas fathers and all others who use our products where we are performing very well and and have benefitted from, as well as shared other areas where we are working to in, our triumphs over the past year. fulfill our full potential. We remain 100% committed to having all of our businesses DRIVING INNOVATIVE SOLUTIONS deliver the highest levels of innovation, Through the decades, Johnson & Johnson customer satisfaction, and overall has advanced with the evolution of performance. science and technology—whether it was through our pioneering development of PHARMACEUTICALS sterile surgery at the turn of the 20th Our Pharmaceutical business has delivered century—or today as we work to develop outstanding and sustained performance a differentiated robotic-assisted surgery for more than seven years, driven by the platform in orthopaedics, build novel successful launch and growth of many regimens to boost T cells and train blockbuster medicines. As we move them to recognize and attack cancer forward, we will drive the continued through our groundbreaking immuno- growth of our existing medicines, while oncology efforts, and focus to create the also delivering on our near-term pipeline. first vaccine for HIV/AIDS. These are And, we remain focused on driving just some of the many examples that robust innovation to address high unmet ** $)"*3."/µ4-&55&3 medical needs and leveraging our strong how we continue to strengthen the commercial capabilities across each of our foundation and simplify operations six therapeutic areas. in Medical Devices. For 2018, we expect our key catalysts for Our near-term priority is to accelerate growth will include: growth though innovation and improved 4FDVSJOH OFX JOEJDBUJPOT UP SFBDINPSF execution with our customers on a global patients and increase market penetration basis. We have also instituted a rigorous for life-changing products such as portfolio management process to better DARZALEX®, IMBRUVICA®, STELARA® focus our efforts. We are launching and XARELLTO®. new commercial models and customer EACH ONE OF Driving best-in-class uptake of experiences in response to healthcare OUR MEDICINES TREMFYAA®, which was approved last consolidation and the development of AND PRODUCTS July in the U.S. and last November in alternative sources for healthcare. We OFFERS A the EU. are also seeing an increasing impact of technology and data on the products LIFESAVING OR 5IF HSPXUI PG"DUFMJPO QSPEVDUT and services we are delivering to LIFE-CHANGING 5IF TVDDFTTGVM MBVODI PG &3-&"%" improve outcomes in a cost-effective SOLUTION THAT in the U.S. manner. Additionally, we will complete GIVES NEW HOPE 4VCNJUUJOH SFHVMBUPSZ BQQMJDBUJPOT GPS our restructuring initiative and achieve TO PATIENTS new molecular entities (NMEs), which the majority of our targeted pre-tax cost AROUND THE include esketamine, erdafitinib, and six savings of $800 million to $1 billion by WORLD. significant line extensions. the end of 2018 to better position us for the evolving marketplace. Some of these names may be new or unfamiliar to you, however each one of Our goal is to build on the topline our medicines and products offers a acceleration we saw in the second half of lifesaving or life-changing solution that 2017. We plan to drive growth in 2018 by: gives new hope to patients around the -BVODIJOH TFWFSBM OFX QSPEVDUT world. We expect to file for the approval across our orthopaedics, surgery and of up to eight compounds by 2021— interventional portfolios. each with more than $1 billion peak 1SPHSFTTJOH UIF EFWFMPQNFOU PG PVS revenue potential—as well as multiple line digital surgery solutions. extensions, many with revenue potential .BYJNJ[JOH OFX NBSLFU HSPXUI exceeding $500 million annually. opportunities in platforms such as stroke and in care delivery locations MEDICAL DEVICES beyond the hospital. We’ve improved quality, execution %FMJWFSJOH B TUFBEZ TUSFBN PG JOOPWBUJWF and competitiveness; filled many critical next generation products to meet a broad portfolio gaps; and built new platforms, set of eye health needs, while using services and digital solutions. This is new channels to effectively connect $)"*3."/µ4-&55&3 *** with customers; and building a premium beloved brands—NEUTROGENA®, surgical channel with superior intraocular AVEENO®, LISTERINE®, TYLENOL®, lenses (IOL technology). MOTRIN® and ZYRTEC®—to more 'VSUIFS FOIBODJOH PVS XPSMEDMBTT consumers around the world, ensuring commercial capabilities, with a relentless our products are available wherever and focus on execution. whenever consumers want to buy them. $POUJOVJOH UP CVJME PVS TUSPOH CSBOE Considering the progress we’ve made in our portfolio through innovation that matters Medical Devices business, we are pleased, to consumers, delivering superior science but never satisfied. We know there is still and differentiated products that are a great deal of work ahead of us to ensure professionally endorsed. we are ideally positioned to consistently WITHOUT deliver innovative solutions and value in I am confident that our Consumer business ANY DOUBT, 2018 and beyond. strategies will position us for success. INCREASING At the same time, we will remain agile in INVESTMENT CONSUMER adapting to and addressing the needs of IN INNOVATION Despite the global category slowdowns a rapidly changing market, continuously IS THE MOST experienced in 2017, we were largely evolving our capabilities and delivering IMPORTANT able to retain our share gains from 2016. relevant solutions. ASPECT OF In the latter half of 2017, we launched OUR STRATEGY. several new products that will position VALUE-CREATING us well in 2018 and we will continue to COLLABORATIONS innovate throughout the year. As consumers Without any doubt, increasing investment change their shopping habits, our business in innovation is the most important aspect has evolved to ensure our products are of our strategy. In 2017, we achieved well-positioned in both traditional and record levels of investment: $10.6 billion emerging channels. We are using our global in R&D and $35.2 billion in M&A.
Load more

Recommended publications
  • From the Academy
    FROM THE ACADEMY Joint American Academy of DermatologyeNational Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy Craig A. Elmets, MD (Co-Chair),a HenryW.Lim,MD,b Benjamin Stoff, MD, MA,c Cody Connor, MD,a Kelly M. Cordoro, MD,d Mark Lebwohl, MD,e AprilW.Armstrong,MD,MPH,f Dawn M. R. Davis, MD,g Boni E. Elewski, MD,a Joel M. Gelfand, MD, MSCE,h Kenneth B. Gordon, MD,i AliceB.Gottlieb,MD,PhD,j Daniel H. Kaplan, MD, PhD,k Arthur Kavanaugh, MD,l Matthew Kiselica, BA/BS,m Dario Kivelevitch, MD,n Neil J. Korman, MD, PhD,o Daniela Kroshinsky, MD, MPH,p Craig L. Leonardi, MD,q Jason Lichten, MD,m NehalN.Mehta,MD,MSCE,r Amy S. Paller, MD,s Sylvia L. Parra, MD,t Arun L. Pathy, MD,u Elizabeth A. Farley Prater, MD,v Reena N. Rupani, MD,e Michael Siegel, PhD,m BruceE.Strober,MD,PhD,w,x Emily B. Wong, MD,y Jashin J. Wu, MD,z Vidhya Hariharan, PhD,aa and Alan Menter, MD (Co-Chair)n Birmingham, Alabama; Detroit, Michigan; Atlanta, Georgia; San Francisco, Los Angeles, San Diego, and Irvine, California; New York, New York; Rochester, Minnesota; Philadelphia and Pittsburgh, Pennsylva- nia; Milwaukee, Wisconsin; Portland, Oregon; Dallas and San Antonio, Texas; Cleveland, Ohio; Boston, Massachusetts; St. Louis, Missouri; Bethesda, Maryland; Chicago and Rosemont, Illinois; Sumter, South Carolina; Centennial, Colorado; Oklahoma City, Oklahoma; Farmington, Connecticut; and Waterloo, Ontario, Canada Psoriasis is a chronic inflammatory disease involving multiple organ systems and affecting approximately 3.2% of the world’s population.
    [Show full text]
  • Mouth Rinses
    Mouth Rinses We may recommend a mouth rinse to you for one or more of the following reasons: Periodontal Disease, Gingivitis, Halitosis (bad breath), sensitive teeth, decay or increased risk of decay, dry mouth, minor mouth sore or irritation. Red= RX only Blue= Available through your dentist only Green= Over the counter *Common side effects found with many mouth rinses include the possibility of staining. We still encourage you to use the rinse that treats your problem because none of the stains these rinses cause are permanent. With good oral hygiene on your part, using your bleaching trays and bleach as needed, you can keep the staining to a minimum. If there is any staining that you can’t prevent, it can always be easily removed by your hygienist at your next cleaning. If you have periodontal disease or Gingivitis, we may recommend an antimicrobial/antiseptic type rinse. These rinses kill germs, reduce plaque, redness, swelling and bleeding when used in conjunction with proper brushing and flossing. Some common examples of antiseptic rinses are: Peridex or Perioguard oral rinses are available by prescription only. Active ingredient is chlorhexidine gluconate .12%. These also contain alcohol 11.6%. Can cause staining of the teeth*, taste alteration and dry mouth. Periomed Oral rinse is available through your dentist only. Active ingredient is stannous fluoride .63%. It is alcohol free. Periomed provides antimicrobial activity for up to 8 hours. Also promotes enamel remineralization, and helps reduce sensitivity. Can cause staining* and dry mouth. Listerine Antiseptic: Active ingredient is alcohol 26.9% in the original gold Listerine, and 21.6% in the other flavors.
    [Show full text]
  • (2) January 2020 CVJ.Pmd
    DOI: https://doi.org/10.3329/cardio.v12i2.47994 Special Article Clarence Walton Lillehei: The Pioneer Open Heart Surgeon Md Anisuzzaman, Nazmul Hosain Department of Cardiac Surgery, Chattogram Medical College Key Words : (Cardiovasc. j. 2020; 12(2): 145-148) Walton Lillehei, Open heart surgery. Introduction: Wangensteen provided a creative environment that Heart as an organ was always a difficult territory produced many brilliant surgeons, and he took a for the surgeons. Famous surgeon Stephen Paget special interest in young Lillehei. in 1895 wrote, “Surgery of the heart has probably In 1949, Dr. Lillehei was appointed a fulltime reached the limit set by the nature, no new instructor of surgery at the University of methods, and no new discovery can overcome the Minnesota Medical School. He began to work his natural difficulties that attend a wound of the way up the academic ladder towards a clinical heart”. But surgeons like Axel Cappelen of Norway professorship. The following year, however fate in 1895, Ludwig Rehn of Germany in 1896 did the dealt him a cruel blow: he was diagnosed with job very well by repairing stab injuries of the heart. lymphosarcoma of the parotid gland and was given But these were rare achievements. Virtually there at most, a 10% chance of surviving for 5 years. was no safe surgical approach or method to deal The day after he finished his senior residency, the heart well before the 1950s. C W Lillehei and Lillehei underwent extensive head and neck his colleagues brought about these changes to surgery at the hands of Dr. Wangensteen and Dr.
    [Show full text]
  • Women in Business Awards Luncheon at the Hotel Irvine, Where Aston Martin Americas President Laura Schwab Delivered the Keynote Address
    10.5.20 SR_WIB.qxp_Layout 1 10/2/20 12:14 PM Page 29 WOMEN IN BUSINESS NOMINEES START ON PAGE B-60 INSIDE 2019 WINNERS GO BIG IN IRVINE, LAND NEW PARTNERS, INVESTMENTS PAGE 30 PRESENTED BY DIAMOND SPONSOR PLATINUM SPONSORS GOLD SPONSOR SILVER SPONSORS 10.5.20 SR_WIB.qxp_Layout 1 10/2/20 1:36 PM Page 30 30 ORANGE COUNTY BUSINESS JOURNAL www.ocbj.com OCTOBER 5, 2020 Winning Execs Don’t Rest on Their Laurels $1B Cancer Center Underway; Military Wins; Spanish Drug Investment Orange County’s business community last year celebrated the Business Journal’s 25th annual Women in Business Awards luncheon at the Hotel Irvine, where Aston Martin Americas President Laura Schwab delivered the keynote address. The winners, selected from 200 nominees, have not been resting on their laurels, even in the era of the coronavirus. Here are updates on what the five winners have been doing. —Peter J. Brennan Avatar Partners City of Hope Shortly after Marlo Brooke won the Busi- (AR) quality assurance solution for the U.S. As president of the City of Hope Orange employees down from Duarte. Area univer- ness Journal’s award for co-founding Hunt- Navy for aircraft wiring maintenance for the County, Annette Walker is orchestrating a sities could partner with City of Hope. ington Beach-based Avatar Partners Inc., Naval Air Systems Command’s Boeing V- $1 billion project to build one of the biggest, While the larger campus near the Orange she was accepted into the Forbes Technol- 22 Osprey aircraft. and scientifically advanced, cancer research County Great Park is being built, Walker in ogy Council, an invitation-only community Then the Air Force is using Avatar’s solu- centers in the world.
    [Show full text]
  • 2015 Annual Report
    ANNUAL REPORT 2015 MARCH 2016 TO OUR SHAREHOLDERS ALEX GORSKY Chairman, Board of Directors and Chief Executive Officer This year at Johnson & Johnson, we are proud this aligned with our values. Our Board of WRITTEN OVER to celebrate 130 years of helping people Directors engages in a formal review of 70 YEARS AGO, everywhere live longer, healthier and happier our strategic plans, and provides regular OUR CREDO lives. As I reflect on our heritage and consider guidance to ensure our strategy will continue UNITES & our future, I am optimistic and confident in the creating better outcomes for the patients INSPIRES THE long-term potential for our business. and customers we serve, while also creating EMPLOYEES long-term value for our shareholders. OF JOHNSON We manage our business using a strategic & JOHNSON. framework that begins with Our Credo. Written OUR STRATEGIES ARE BASED ON over 70 years ago, it unites and inspires the OUR BROAD AND DEEP KNOWLEDGE employees of Johnson & Johnson. It reminds OF THE HEALTH CARE LANDSCAPE us that our first responsibility is to the patients, IN WHICH WE OPERATE. customers and health care professionals who For 130 years, our company has been use our products, and it compels us to deliver driving breakthrough innovation in health on our responsibilities to our employees, care – from revolutionizing wound care in communities and shareholders. the 1880s to developing cures, vaccines and treatments for some of today’s most Our strategic framework positions us well pressing diseases in the world. We are acutely to continue our leadership in the markets in aware of the need to evaluate our business which we compete through a set of strategic against the changing health care environment principles: we are broadly based in human and to challenge ourselves based on the health care, our focus is on managing for the results we deliver.
    [Show full text]
  • Johnson & Johnson
    JOHNSON & JOHNSON FORM 10-K (Annual Report) Filed 02/22/13 for the Period Ending 12/30/12 Address ONE JOHNSON & JOHNSON PLZ NEW BRUNSWICK, NJ 08933 Telephone 732-524-2455 CIK 0000200406 Symbol JNJ SIC Code 2834 - Pharmaceutical Preparations Industry Biotechnology & Drugs Sector Healthcare Fiscal Year 12/12 http://www.edgar-online.com © Copyright 2013, EDGAR Online, Inc. All Rights Reserved. Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ANNUAL REPORT PURSUANT TO SECTION 13 OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 30, 2012 Commission file number 1-3215 JOHNSON & JOHNSON (Exact name of registrant as specified in its charter) New Jersey 22-1024240 (State of incorporation) (I.R.S. Employer Identification No.) One Johnson & Johnson Plaza New Brunswick, New Jersey 08933 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (732) 524-0400 SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT Title of each class Name of each exchange on which registered Common Stock, Par Value $1.00 New York Stock Exchange Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes No Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
    [Show full text]
  • 1 Brief Report: the Virucidal Efficacy of Oral Rinse Components Against SARS-Cov-2 in Vitro Evelina Statkute1†, Anzelika Rubin
    bioRxiv preprint doi: https://doi.org/10.1101/2020.11.13.381079; this version posted November 13, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY-ND 4.0 International license. Brief Report: The Virucidal Efficacy of Oral Rinse Components Against SARS-CoV-2 In Vitro Evelina Statkute1†, Anzelika Rubina1†, Valerie B O’Donnell1, David W. Thomas2† Richard J. Stanton1† 1Systems Immunity University Research Institute, Division of Infection & Immunity, School of Medicine, Heath Park, Cardiff, CF14 4XN 2Advanced Therapies Group, School of Dentistry, Cardiff University, Heath Park, Cardiff CF14 4XY, UK †These authors contributed equally * Correspondence: [email protected], [email protected] Running title: Virucidal Activity of Mouthwashes Keywords: SARS-CoV2, mouthwash, lipid, envelope Disclosure: Venture Life Group plc provided information on mouthwash formulations employed in the study, but had no role in funding, planning, execution, analysis or writing of this study. A separate study funded to Cardiff University by Venture Life Group is assessing in vivo efficacy of CPC in patients with COVID19. The investigators declare no direct conflicts exist. 1 bioRxiv preprint doi: https://doi.org/10.1101/2020.11.13.381079; this version posted November 13, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY-ND 4.0 International license.
    [Show full text]
  • EIR) Expertise Guide
    v MEDICAL INDUSTRY LEADERSHIP INSTITUTE 2019–2020 Executive in Residence (EIR) Expertise Guide John J. Alexander, ChEng, MDA [email protected] President, Business Development Advisors, Inc.; Chairman, Twin Cities Angels Funds Roles: Corporate Development, CEO, Management Team Coach Background: St. Jude Medical, Baxter Healthcare, W.R. Grace, GE, Alcoa. Private companies—Wide Range Expertise: (Markets) Medical Technology: devices, diagnostics (Functions) Corporate Development: M&A, strategic alliances, divestitures, licensing, corporate ventures, internal startups starting, building emerging technology businesses and turning-around established businesses; (Functions) venture capital & angel capital, PIPE, venture debt, debt Susan Alpert, PhD, MD [email protected] Principal, SFA Consulting Roles: Regulatory affairs, device evaluation, pediatrician with specialty in infectious disease Background: Medtronic, C.R. Bard, FDA Expertise: Regulatory affairs, FDA, clinical trials, medical devices, business strategy Daniel L. Cosentino, MBA [email protected] CEO, ElectroSea ROLES: CEO, Entrepreneur, Board Advisor, Investor BACKGROUND: Founder & CEO, Cardiocom; VP/GM, Medtronic; Board Advisor, Minnetronix Neuro EXPERTISE: Digital health, medical devices, entrepreneurship, new product development, general management Michael Finch, PhD [email protected] Research Manager, Children’s Hospital MN Roles: Faculty, instructor, research director Background: Carlson School of Management, Children’s Hospital, School of Public Health, UMN, UnitedHealth Group Expertise: Cost, quality and financing of health care in public and private market, research methods and evaluation, valuation of medical innovations, hospital safety, role of physician communication in health care Paul J. Gam, MBA, CGMA, CPA (Inactive) [email protected] Founder and CEO, Zurich Medical Roles: Various management and advisory roles Background: Founder and CEO, Zurich Medical; Board Member, Blue Cross Blue Shield of MN; Partner, Grace Associates; VP International Development, St.
    [Show full text]
  • 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.
    [Show full text]
  • 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.
    [Show full text]
  • Approved Prenatal Medications Pain Medications • Tylenol
    Approved Prenatal Medications Pain Medications Tylenol (acetaminophen) for minor aches and pains, headaches. (Do not use: Aspirin, Motrin, Advil, Aleve, Ibuprofen.) Coughs/Colds Robitussin (Cough) Robitussin DM (non-productive cough) DO NOT USE TILL OVER 12 WEEKS Secrets and Vicks Throat Lozenges Mucinex Sore Throat Chloraseptic spray Saline Gargle Sucrets and Vicks Throat Lozenges Antihistamines/Allergies Zyrtec Claritin Benadryl Dimetapp Insomnia Benadryl Unison Hemorrhoids Preparation H Tucks Anusol Diarrhea Imodium (1-2 doses- if it persists please notify the office) BRAT diet (bananas, rice, applesauce, toast) Lice RID (only!) DO NOT USE Kwell Itching Benadryl Calamine or Caladryl Lotion Hydrocortisone cream Heartburn, Indigestion, Gas Tums Gas-X Mylanta Pepcid Maalox Zantac *DO NOT USE PEPTO BISMOL- it contains aspirin Decongestants Sudafed Robitussin CF- Only if over 12 weeks Tavist D Ocean Mist Nasal Spray (saline solutions) Nausea Small Frequent Meals Ginger Ale Vitamin B6 Sea Bands Yeast Infections Monistat Mycolog Gyne-lotrimin Toothache Orajel May see dentists, have cavity filled using Novocain or lidocaine, have x-rays with double lead shield, may have antibiotics in the Penicillin family (penicillin, amoxicillin) Sweetners- all should be consumed in moderation with water being consumed more frequently Nutrisweet (aspartame) Equal (aspartame) Splenda (sucralose) Sweet’n Low (saccharin) *note avoid aspartame if you have phenylketonuria (PKU) Constipation Colace Fibercon Citrucel Senokot Metamucil Milk of Magnesia Fiberall Miralax Eczema Hydrocortisone Cream Medications to AVOID Accurate Lithium Paxil Ciprofloxacin Tetracycline Coumadin Other Chemicals to AVOID Cigarettes Alcohol Recreational Drugs: marijuana, cocaine, ecstasy, heroin .
    [Show full text]
  • SEC Form 10-K Annual Report
    e10vk 10-K 1 y80744e10vk.htm FORM 10-K Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ANNUAL REPORT PURSUANT TO SECTION 13 OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended January 3, 2010 Commission file number 1-3215 JOHNSON & JOHNSON (Exact name of registrant as specified in its charter) New Jersey 22-1024240 (State of incorporation) (I.R.S. Employer Identification No.) One Johnson & Johnson Plaza New Brunswick, New Jersey 08933 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (732) 524-0400 SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT Title of each class Name of each exchange on which registered Common Stock, Par Value $1.00 New York Stock Exchange Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes þ No o Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes o No þ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No o Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
    [Show full text]