DOCSLIB.ORG

1 | Page Danae Christodoulou, US Food and Drug Administration

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
1 | Page Danae Christodoulou, US Food and Drug Administration Bios Danae Christodoulou, US Food and Drug Administration [email protected] Danae Christodoulou is an Acting Branch Chief in the Office of New Drug Products/OPQ/CDER. Danae joined FDA in 1998 and served as primary reviewer in the Office of New Drugs, as a Chemistry, Manufacturing and Controls Lead and Acting Branch Chief since 2013. Danae has a background in Inorganic Chemistry and received her Ph.D. from the University of Michigan, Ann Arbor, MI. Prior to FDA, Danae worked at Johnson Matthey Inc. R&D Drug Discovery as a Senior Research Chemist and at the National Cancer Institute, in Frederick, MD. Danae served as the Chair for the EI Implementation Working Group at FDA. Marjorie Coppinger, Teva [email protected] Marjorie Coppinger is Head of Global Generic Research Quality (SOD/SSL) for Teva Pharmaceuticals. She received B.A in Chemistry from the University of Notre Dame, Maryland and has over 21 years of experience at Teva Pharmaceuticals in analytical research and development, technical services, manufacturing, quality control, compendial compliance and quality assurance. Currently Ms. Coppinger is Co- Chair of the NJPQCA Compendial Discussion Group and has represented both NJPQCA and GPhA on various USP planning meetings, stakeholder initiatives and project groups for the USP. Elisabeth Corbett, Bristol-Myers Squibb. [email protected] Elisabeth Corbett is an Associate Director, CMC, in Global Regulatory Sciences at Bristol-Myers Squib in Pennington, NJ. She joined Bristol-Myers Squibb as a process engineer in Process Chemistry R&D in 2001. In 2008, she relocated to San Antonio, Texas and served in Quality roles before returning to CMC Regulatory at BMS in 2012. In this role she has supported CMC lifecycle management of HIV and oncology products as well as of early development assets. Additionally, she is the regulatory lead for the implementation of ICH Q3D at BMS. She holds a B.S. in Chemical Engineering and Biology from Carnegie Mellon University and a M.B.A from New York University. 1 | Page Peter Colvin, Merck & Co., Inc. [email protected] Peter Colvin is an Associate Principal Scientist with the Manufacturing Division of Merck & Co., Inc. As part of Sterile & Liquids Commercialization, Peter specializes in the scale-up, tech transfer, process qualification, and launch of Merck’s sterile drug product pipeline. Peter has led drug product teams for both small and large molecules, including combination products. Peter started at Merck in 2003, and spent the first 5 years of his career in the sterile pilot plant leading drug product manufacture of clinical supplies. Prior to joining Merck, Peter earned a B.S. in Chemical Engingeering at Penn State University and an M.S. in Chemical Engineering Practice at M.I.T. David J. Fillar, Perrigo [email protected] David Fillar is a Quality Control Manager at the Allegan Site for the Perrigo Company. Current responsibilities at Perrigo include management of Lifecycle Analytical Services, Compendial Affairs, QC Informatics Support, Microbiology, and QC Purchased Materials. David has 25 years of experience in the Pharmaceutical Industry. Responsibilities have included Laboratory Systems, Process Validation, Environmental Monitoring, Quality Assurance, Supplier Quality Management, Operational Support, and New Products Project Management. David holds an MBA from Grand Valley State University and a Bachelor’s degree in Chemistry from Western Michigan University. Josh Foote, Perrigo [email protected] Josh Foote is a Senior Scientist in the Analytical Research and Development Department at Perrigo Company in Allegan, Michigan. Earlier in his career, he provided analytical support for a variety of drug product filings with a primary focus on small molecule organic impurities. In his current role his responsibilities include organic impurity method development for monograph products as well as evaluating new drug products for elemental impurity risks. He has helped establish an internal risk assessment and control strategy program for elemental impurities compliance and is a member of the Coalition for Rational Implementation of the Elemental Impurity Requirements. Josh received his Bachelor of Science degree in chemistry from Western Michigan University. 2 | Page John Glennon, GlaxoSmithKline [email protected] John Glennon has 24 years experience in pharmaceutical analysis, focused primarily on analytical development and method transfer. This includes working at the GSK-sponsored Anti- Doping Science Laboratory during the London 2012 Olympic and Paralympic games. He is currently a member of the Product Quality and NPI Analytical group in GSK Global Manufacturing and Supply, and is based at the GSK manufacturing facility in Zebulon, NC. With a personal focus on Solid Oral Dose products, he is also a member of the group within GSK that sets global standards of workmanship for analytical testing. John has been working on the implementation of ICH Q3D within GSK for nearly four years. He is a member of an inter– industry consortium that is aiming to share data and align approaches to Q3D. John holds a B.Sc. in Chemistry from the University of Birmingham, UK, and an MS in analytical chemistry from North Carolina State University. Andre Hermans, Merck & Co., Inc. [email protected] Andre Hermans is a Principal Scientist in the Analytical Sciences Division at Merck and Co. in West Point, PA. He received is PhD from the University of North Carolina in Chapel Hill in Analytical Chemistry before joining Merck in 2007. During his time at Merck, Andre supports analytical method development and process development in the small molecule solid oral dosage area. In this function he co-authored several IND and NDA applications mainly for enabled formulations. Additionally, he is leading Merck’s efforts around in-vivo predictive technologies and dissolution innovations as well as the implementation of ICH Q3D for new filings and member of several industry-wide ICH Q3D working groups. Samina Hussain, Exova Health Sciences [email protected] As the Metals Group Leader at Exova, Ms. Hussain has over 19 years of extensive experience in testing hundreds of different matrices for metal content by ICP-MS and ICP-OES. Her expertise in preparing samples for analysis is the cornerstone of her knowledge and includes simple acid digestions, organic solvent sample preparations, and microwave techniques. Over the last several years she has been working with the pharmaceutical and dietary supplement industries on implementation of USP <232>, <233>, <2232>, and ICHQ3D and has performed many method validations. 3 | Page Alison Ingham, Health Canada [email protected] Alison Ingham obtained her B.Sc. (Chemistry and Biochemistry) at the University of the Witwatersrand in South Africa and her Ph.D. in Bioinorganic Chemistry from the University of Victoria, Canada. After graduation she lectured at the University of Ottawa, before joining Health Canada. During her tenure at Health Canada, Alison has been involved with assessing the certification process at the European Directorate for the Quality of Medicines, and was appointed an Assessor by EDQM in 2006. She was the Manager of Product Assessment in the Nutrient and Isolates Division at the Natural Health Products Directorate. Currently she is a Manager in the Bureau of Pharmaceutical Sciences of the Therapeutic Products Directorate of Health Canada where her responsibilities include assessment of generic drugs as well as guidance development. Joy E. Mason, Eli Lilly and Company [email protected] Joy Mason is a Quality Consultant in Compendial Affairs at Eli Lilly and Company, with 28 years of experience in pharmaceutical quality systems, microbiological testing, project management, change management, and six sigma initiatives. Joy received her Bachelor’s degree in Microbiology at Miami of Ohio, and her Master’s degree in Pharmaceutical Sciences at Butler University in Indiana. She received her six sigma black belt certification from Purdue University in Indiana in 2013. She has completed four six sigma initiatives to support laboratory operations. She has also coordinated the implementation of several large-scale Compendial changes for Lilly labs. Denise McClenathan, Procter & Gamble [email protected] Denise is currently Senior Scientist and Group Leader in Procter & Gamble’s Global Elemental Analysis Capability. She joined P&G as a Scientist in 2004 after receiving a B.A. in Chemistry from Saint Mary’s University of Minnesota and a Ph.D. in Analytical Chemistry from Indiana University. At IU, Denise researched plasma source time-of-flight mass spectrometry, studying with Professor Gary Hieftje. At P&G, she is responsible for strategies to address an array of complex elemental analysis problems, across all of P&G’s consumer products programs, from upstream innovation projects through marketed-product compliance needs. Denise is currently a member of the Technical and Analytical Challenges Team sponsored by IPEC and her research interests include instrumentation and methodologies for elemental analysis, spanning microwave digestion, ICP-OES, and ICP-MS, as well as validation strategies. Denise is the author of 16 publications and patents. 4 | Page David R. Schoneker, Colorcon [email protected] David R. Schoneker is the Director of Global Regulatory Affairs at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and market expansion
Load more

Recommended publications
  • Teva to Acquire Cogenesys
    TEVA PHARMACEUTICALS AND PERRIGO COMPANY ANNOUNCE THE U.S. LAUNCH OF GENERIC TEMOZOLOMIDE Jerusalem and Allegan, Mich. – August 12, 2013 – Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Perrigo Company (NYSE: PRGO;TASE) today announced the launch of the generic equivalent to Temodar® (temozolomide). Teva will manufacture, market and distribute the product in the U.S. and both companies will equally share in the cost and profitability of the product in the U.S. Teva was first to file, making the product eligible for 180 days of marketing exclusivity. This product is the generic equivalent to Temodar® (temozolomide), indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment and refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. Temodar® had annual sales of approximately $423 million in the United States, according to IMS data as of December 31, 2012. The launch of this product provides a quality alternative, making cancer therapy more cost effective for patients who suffer from this devastating cancer. Perrigo’s Chairman, President and CEO Joseph C. Papa stated, “This first-to-file launch with our partner Teva is another example of our focus to manufacture complex API’s. We are pleased to offer this important product to patients in the United States.” “We are pleased to partner with Perrigo to offer patients a high-quality, less expensive alternative of this important medicine. This launch demonstrates Teva’s commitment to continue to pursue first-to-market opportunities and enhance the value of our portfolio by concentrating on high-margin, low competition markets,” stated Allan Oberman, President and CEO of Teva Americas Generics.
    [Show full text]
  • Teva Respiratory LLC V. Perrigo Pharmaceuticals
    Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.1 Page 1 of 21 IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF MICHIGAN ) ) TEVA RESPIRATORY, LLC, and TEVA ) PHARMACEUTICALS USA, INC., ) ) Civil Action No. 20-00207 ) Plaintiffs, ) ) v. ) ) PERRIGO PHARMACEUTICALS CO., and ) PERRIGO COMPANY PLC, ) ) Defendants. ) ) ) COMPLAINT Plaintiffs Teva Respiratory, LLC (“Teva Respiratory”) and Teva Pharmaceuticals USA, Inc. (“Teva USA”) (collectively, “Plaintiffs” or “Teva”), allege against defendants Perrigo Pharmaceuticals Co., and Perrigo Company plc (collectively, “Defendants” or “Perrigo”) as follows: INTRODUCTION 1. This case arises from Perrigo’s deliberate and unlawful attempt to misappropriate Teva’s federally registered trade dress for Teva’s revolutionary ProAir RespiClick® rescue respiratory inhaler and usurp and tarnish Teva’s goodwill. 2. Teva’s ProAir RespiClick® is the only albuterol rescue inhaler on the market that is “breath-activated”; it does not require any hand-breath coordination during inhalation. In other words, Teva’s ProAir RespiClick® enables users to get a rescue dose of albuterol during an asthma or COPD attack simply by breathing in. ProAir RespiClick® is a leading drug for the treatment of bronchospasm. -1- ACTIVE/102581507.4 Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.2 Page 2 of 21 3. Teva’s ProAir RespiClick® design includes a white body and a distinctive red cap. Teva has a federally registered trademark on the ProAir RespiClick® design. 4. Teva also sells an earlier-generation albuterol rescue inhaler named ProAir® HFA, both as a branded product and as an authorized generic product.
    [Show full text]
  • Wellbutrin Xl : Civil Action Antitrust Litigation : : : No
    Case 2:08-cv-02433-GAM Document 419 Filed 05/11/12 Page 1 of 95 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA IN RE: WELLBUTRIN XL : CIVIL ACTION ANTITRUST LITIGATION : : : NO. 08-2431 (direct) : NO. 08-2433 (indirect) MEMORANDUM McLaughlin, J. May 11, 2012 TABLE OF CONTENTS Page I. Legal and Factual Background.. 2 A. The Drug Approval Process and Regulatory Framework. 2 B. The Citizen Petition Process. 4 C. Wellbutrin IR, Wellbutrin SR, and Wellbutrin XL.. 5 D. Noerr-Pennington Immunity and the Sham Exception. 7 E. Standard of Proof as to Objective Baselessness. 11 II. Overview.. 13 III. Biovail’s Conduct. 15 A. The Anchen Lawsuit. 15 B. The Watson Lawsuit. 26 C. The Abrika Lawsuit. 28 D. The Impax Lawsuit.. 43 E. The Citizen Petition. 50 IV. GSK’s Conduct. 82 A. The Impax and Watson Lawsuits.. 84 B. Biovail’s Citizen Petition. 86 Case 2:08-cv-02433-GAM Document 419 Filed 05/11/12 Page 2 of 95 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA IN RE: WELLBUTRIN XL : CIVIL ACTION ANTITRUST LITIGATION : : : NO. 08-2431 (direct) : NO. 08-2433 (indirect) MEMORANDUM McLaughlin, J. May 11, 2012 Wellbutrin XL is a once-a-day antidepressant containing the active pharmaceutical ingredient bupropion hydrochloride. It is produced by Biovail Corporation, Biovail Laboratories, Inc., and Biovail Laboratories International SRL1 (together, “Biovail”), and distributed by SmithKline Beecham Corporation and GlaxoSmithKline, PLC (together, “GSK”). The plaintiffs, direct and indirect purchasers of Wellbutrin XL, have sued Biovail and GSK for illegally conspiring to prevent generic versions of Wellbutrin XL from entering the American market by filing sham patent infringement lawsuits and a citizen petition with the Food and Drug Administration (“FDA”), and entering into agreements with generic companies to settle the lawsuits.
    [Show full text]
  • 2020 Annual Report Products
    Products 2020 Annual Report From the CEO Dear Fellow Shareholders, Perrigo’s transformation to a pure-play Consumer Self-Care Company has come a long way LQMXVWWZRVKRUW\HDUV:HKDYHUHVWRUHGVXVWDLQDEOHWRSOLQHJURZWKGHOLYHUHGRQRXU¿QDQFLDO SURPLVHVUHFRQ¿JXUHGRXUSRUWIROLRRIEXVLQHVVHVXSGDWHGWKH,7LQIUDVWUXFWXUHDQGSURFHVVHV of the Company, expanded capacity, upgraded leadership talent, installed business intelligence capabilities, built a new product pipeline of over $500 million and re-instilled a sense of pride and energy among our 11,000 team members. Making this even more remarkable, is that we kept the WUDQVIRUPDWLRQRQWUDFNLQWKHIDFHRIWKHJOREDO&29,'SDQGHPLF,KRSH\RXDUHDVSURXGRI3HUULJR¶VJOREDOWHDP DV,DPIRUKRZWKH\ZRUNHGWRNHHSHDFKRWKHUVDIHNHSWRXUHVVHQWLDOSURGXFWVÀRZLQJDQGNHSWRXUWUDQVIRUPDWLRQ to a consumer self-care company on track through all of the personal and professional uncertainty that came their way LQ7KH\DUHKHURHV As a result of their efforts, Perrigo delivered strong net sales growth for the second year in a row in 2020 and World-wide Consumer sales reached a new record high. Equally important, the team stabilized adjusted operating income after a few years of decline even as we invested over $50 million in our business and overcame $35 million RIXQSODQQHGKHDGZLQGVGXHSULPDULO\WR&29,'UHODWHGVDIHW\FRVWVDQGEXVLQHVVLPSDFWIURPWKHZHDNFROG FRXJKDQGÀXVHDVRQUHODWHGWR&29,'¶VLPSDFWRQSXEOLFOLIH$OOLQDOOZHKDGDYHU\VWURQJ\HDU Our transformation efforts reached an essential milestone after the year closed when we announced the sale of RXU3UHVFULSWLRQ3KDUPDFHXWLFDOVEXVLQHVVWR$OWDULV&DSLWDO3DUWQHUV//&7KHWUDQVDFWLRQUHLQIRUFHVRXUDELOLW\
    [Show full text]
  • Quarterly Federal Court Litigation Status Report
    QUARTERLY FEDERAL COURT LITIGATION STATUS REPORT Office of the General Counsel Bureau of Competition Bureau of Consumer Protection Regional Offices March 31, 2017 No. 131 TABLE OF CONTENTS SUMMARY OF CASES................................................................................................................. ii PETITIONS FOR REVIEW ........................................................................................................... 1 A) Orders to Cease and Desist ............................................................................................ 1 B) Rulemakings ................................................................................................................... 2 INJUNCTION AND CONSUMER REDRESS CASES ................................................................ 3 A) Preliminary Injunctions (Mergers/Acquisitions) ............................................................ 3 B) Preliminary Injunctions (Other) ..................................................................................... 4 C) Permanent Injunctions/Consumer Redress ..................................................................... 4 CIVIL PENALTY AND ENFORCEMENT CASES ................................................................... 82 A) Consumer Protection .................................................................................................... 82 B) Competition .................................................................................................................. 89 SUBPOENA AND CID ENFORCEMENT
    [Show full text]
  • GLAXOSMITHKLINE LLC V. TEVA PHARMACEUTICALS USA, INC
    Case: 18-1976 Document: 111 Page: 1 Filed: 10/02/2020 United States Court of Appeals for the Federal Circuit ______________________ GLAXOSMITHKLINE LLC, SMITHKLINE BEECHAM (CORK) LIMITED, Plaintiffs-Appellants v. TEVA PHARMACEUTICALS USA, INC., Defendant-Cross-Appellant ______________________ 2018-1976, 2018-2023 ______________________ Appeals from the United States District Court for the District of Delaware in No. 1:14-cv-00878-LPS-CJB, Chief Judge Leonard P. Stark. ______________________ Decided: October 2, 2020 ______________________ JUANITA ROSE BROOKS, Fish & Richardson, PC, San Diego, CA, argued for plaintiffs-appellants. Also represented by MICHAEL ARI AMON, CRAIG E. COUNTRYMAN, JONATHAN ELLIOT SINGER; ELIZABETH M. FLANAGAN, MICHAEL J. KANE, WILLIAM WOODFORD, Minneapolis, MN; DOUGLAS E. MCCANN, Wilmington, DE. WILLIAM M. JAY, Goodwin Procter LLP, Washington, DC, argued for defendant-cross-appellant. Also represented by JAIME ANN SANTOS; ELAINE BLAIS, J. Case: 18-1976 Document: 111 Page: 2 Filed: 10/02/2020 2 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. ANTHONY DOWNS, ROBERT FREDERICKSON, III, CHRISTOPHER T. HOLDING, ALEXANDRA LU, LANA S. SHIFERMAN, DARYL L. WIESEN, Boston, MA; IRA J. LEVY, New York, NY. HANSJORG SAUER, Biotechnology Innovation Organization, Washington, DC, for amicus curiae Biotechnology Innovation Organization. Also represented by MELISSA A. BRAND; BRIAN PAUL BARRETT, Eli Lilly and Company, Indianapolis, IN. MICHAEL N. KENNEDY, Covington & Burling LLP, Washington, DC, for amicus curiae Pharmaceutical Research and Manufacturers of America. Also represented by STEVEN JOHN WINKELMAN; DAVID EVAN KORN, Pharmaceutical Research and Manufacturers Association of America, Washington, DC. ANDREW CURTIS NICHOLS, Winston & Strawn LLP, Washington, DC, for amicus curiae Association for Accessible Medicines. Also represented by GEORGE C.
    [Show full text]
  • 20200313170134437 to FILE --Actavis Contrave Cert Petition.Pdf
    No. IN THE Supreme Court of the United States ACTAVIS LABORATORIES FL, INC., Petitioner, v. NALPROPION PHARMACEUTICALS LLC Respondent. On Petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit PETITION FOR A WRIT OF CERTIORARI GERARD J. CEDRONE WILLIAM M. JAY THOMAS MCTIGUE IV Counsel of Record GOODWIN PROCTER LLP JAIME A. SANTOS 100 Northern Avenue GOODWIN PROCTER LLP Boston, MA 02210 1900 N Street, N.W. Washington, DC 20036 SCOTT J. BORNSTEIN [email protected] JONATHAN D. BALL (202) 346-4000 RICHARD C. PETTUS JUSTIN A. MACLEAN ALEXANDRA D. VALENTI GREENBERG TRAURIG LLP GOODWIN PROCTER LLP 200 Park Avenue 620 Eighth Avenue New York, NY 10166 New York, NY 10018 March 13, 2020 Counsel for Petitioner QUESTION PRESENTED Under 35 U.S.C. § 112, a patent’s specification must “contain a written description of the invention.” That requirement, a cornerstone of federal patent law, ensures that an inventor can claim patent pro- tection only for what she actually invented. Consistent with this Court’s longstanding di- rective that every element of a patent claim must be treated as material, the Federal Circuit has long held that all elements of a patent’s claims must ac- tually be disclosed in the patent’s specification. But the Federal Circuit has now broken from that estab- lished rule. In the 2-1 decision below, the Federal Circuit announced for the first time that for some claim limitations, a “substantially equivalent” disclo- sure will do. Here, although the claims expressly re- quire testing using one specific method identified by name, the court held that the written description’s disclosure of a different testing method was good enough.
    [Show full text]
  • Trazodone Hydrochloride Tablets, Usp
    TRAZODONE HYDROCHLORIDE- trazodone hydrochloride tablet Lake Erie Medical DBA Quality Care Products LLC ---------- TRAZODONE HYDROCHLORIDE TABLETS, USP Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of trazodone HCl or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Trazodone HCl is not approved for use in pediatric patients. (See WARNINGS, Clinical Worsening and Suicide Risk, PRECAUTIONS, Information for Patients, and PRECAUTIONS, Pediatric Use DESCRIPTION Trazodone Hydrochloride Tablets USP is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1, 2, 4-triazolo[4, 3-a]-pyridin- 3(2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water.
    [Show full text]
  • Printmgr File
    SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934 For the month of November 2011 Commission File Number 0-16174 TEVA PHARMACEUTICAL INDUSTRIES LIMITED (Translation of registrant’s name into English) 5 Basel Street, P.O. Box 3190 Petach Tikva 49131 Israel (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F: Form 20-F ⌧ Form 40-F Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): TEVA PHARMACEUTICAL INDUSTRIES LIMITED INDEX Page Consolidated Statements of Income 2 Consolidated Balance Sheets 3 Consolidated Statements of Cash Flow 4 Notes to Condensed Consolidated Financial Statements 5 Operating and Financial Review and Prospects 23 Risk Factors 43 Quantitative and Qualitative Disclosures About Market Risk 44 Legal Proceedings 44 Exhibits As listed below, attached as Exhibit 101 to this Report on Form 6-K is certain information contained in this Report on Form 6-K of Teva Pharmaceutical Industries Limited relating to the three and nine months ended September 30, 2011, formatted in XBRL (Extensible Business Reporting Language). Users of this data are advised, in accordance with Rule 406T of Regulation S-T promulgated by the Securities and Exchange Commission, that this Interactive Data File is deemed not filed or part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of section 18 of the Securities Exchange Act of 1934, and otherwise is not subject to liability under these sections.
    [Show full text]
  • Generic Pharmaceuticals Mdl 2724 Pricing Antitrust Litigation 16-Md-2724 ______Hon
    IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA __________________________________________ IN RE: GENERIC PHARMACEUTICALS MDL 2724 PRICING ANTITRUST LITIGATION 16-MD-2724 __________________________________________ HON. CYNTHIA M. RUFE THIS DOCUMENT RELATES TO: Civil Action Nos. The State Attorneys General Litigation 17-3768 The Kroger Co. v. Actavis Holdco U.S., Inc. 18-284 1199SEIU Nat’l Benefit Fund v. Actavis Holdco US, Inc. 18-2401 West Val Pharmacy v. Actavis Holdco U.S., Inc. 18-2533 Ahold USA, Inc. v. Actavis Holdco U.S., Inc. 18-2641 Humana Inc. v. Actavis Elizabeth, LLC 18-3299 Marion Diagnostic Center, LLC v. McKesson Corp. 18-4137 _________________________________________ OPINION Rufe, J. August 15, 2019 This is a multidistrict antitrust litigation involving allegations that certain pharmaceutical companies engaged in an unlawful scheme or schemes to fix, maintain, and stabilize prices, rig bids, and engage in market and customer allocations of certain generic pharmaceutical products. In this Opinion, the Court considers Defendants’ joint motion to dismiss claims asserting the existence of an overarching multi-drug conspiracy in the following pleadings (collectively, the “Overarching Complaints”): Direct Purchaser Plaintiffs’ First Amended Class Action Complaint ¶¶ 108-1211; End Payor Plaintiffs’ Amended Class Action Complaint ¶¶ 99-1812; Indirect Reseller Plaintiffs’ Amended Overarching Complaint ¶¶ 65-723; Kroger Plaintiffs’ Amended Complaint ¶¶ 813-324; Marion Plaintiffs’ Second Amended Complaint, ¶¶ 51-595; Humana Inc.’s Second Amended Complaint ¶¶ 261-726; and the Plaintiff States’ Consolidated Amended 1 The Direct Purchaser Plaintiffs (“DPPs”) allege they directly purchased generic pharmaceuticals from Defendants. They include the following drug purchasing cooperatives and retail pharmacy operators: Ahold, USA, Inc.; César Castillo, Inc.; FWK Holdings, LLC; KPH Healthcare Services, Inc.
    [Show full text]
  • Other As Well (Not Just with Teva)
    No. 19-1010 ================================================================================================================ In The Supreme Court of the United States --------------------------------- ♦ --------------------------------- ACTAVIS HOLDCO US, INC., et al., Petitioners, v. STATE OF CONNECTICUT, et al., Respondents. --------------------------------- ♦ --------------------------------- On Petition For Writ Of Certiorari To The United States Court Of Appeals For The Third Circuit --------------------------------- ♦ --------------------------------- RESPONDENTS’ APPENDIX TO BRIEF IN OPPOSITION TO PETITION FOR WRIT OF CERTIORARI --------------------------------- ♦ --------------------------------- WILLIAM TONG Attorney General of Connecticut *CLARE KINDALL Solicitor General W. J OSEPH NIELSEN ROBERT J. DEICHERT Assistant Attorneys General OFFICE OF THE ATTORNEY GENERAL 165 Capitol Avenue Hartford, CT 06106 (860) 808-5261 [email protected] Counsel for State of Connecticut and Liaison Counsel for Respondent States *Counsel of Record (Additional Counsel On Inside Cover And On Signature Pages) ================================================================================================================ ROBERTA D. LIEBENBERG JEFFREY S. ISTVAN FINE, KAPLAN AND BLACK, R.P.C. One South Broad Street, 23rd Floor Philadelphia, PA 19107 (215) 567-6565 rliebenberg@finekaplan.com Lead Counsel for the End-Payer Plaintiffs DIANNE M. NAST NASTLAW LLC 1101 Market Street, Suite 2801 Philadelphia, PA 19107 (215) 923-9300 [email protected] Lead
    [Show full text]
  • US Says Teva Antidepressant Is Ineffective 3 October 2012, by Matthew Perrone
    US says Teva antidepressant is ineffective 3 October 2012, by Matthew Perrone (AP)—Teva Pharmaceuticals has stopped shipping longer appropriate." its generic version of a popular antidepressant off the market after a U.S. government analysis "Based on the information we had available at that showed the pill does not work properly. time we concluded that the 150 milligram strength was doing what it should, and that it was The Food and Drug Administration said acceptable to extrapolate those findings to the 300 Wednesday it asked Teva to withdraw Budeprion milligram strength" said Barbara Davit, director of XL 300 after new testing showed the drug releases bioequivalence for FDA's office of generic drugs. its key ingredient faster than the original drug Agency officials said they decided to perform their Wellbutrin XL 300, made by GlaxoSmithKline. own study after continuing to receive complaints about Budeprion XL 300. A spokeswoman for Teva said the company stopped shipping the drug last Thursday. The FDA said it completed its study of the two drugs in 24 adult patients in August, and notified The action contradicts the FDA's previous update Teva of the findings last month. on the issue in 2008, when regulators said the drugs are essentially the same. That review came "The role of patients and health care professionals after hundreds of patients complained that Teva's in sharing their experiences with generic versions drug did not work as well or caused side effects of Wellbutrin XL 300 mg contributed to further like headaches, anxiety and insomnia. studies, which led to this action," said Dr.
    [Show full text]