Generics+-+11-03-08+minutes

Meeting Minutes for SPL Generic Sub-Team Meeting November 3, 2008 , 1 pm ET  These minutes along with the presentations will be posted on the Wiki at http://SPL-Work-Group.wikispaces.com.   (Next Meeting Monday, October 17, 2008 at 1:00 PM ET unless cancelled)   1. Lots of new members joining from GPhA meeting in Bethesda.  2. Jeffery Karp officially co-chair of generics sub-group.  3. Summary of discussion of DUNS numbers. Tom Marsden, from Dun and Bradstreet presented at both meetings. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';"> <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Getting your companies DUNS number is free. Getting other companies DUNS numbers - $429 annual + $3.55 per number. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';"> <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">We, the SPL producers, need to find the exact way of getting external/other company duns number from D&B. A flowchart with contacts would be useful. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';"> <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">The group requests a dedicated group at D&B for these requests. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';"> <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Question 1 <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Q: Do DUNS numbers ever change? <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">A: Rarely <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';"> <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Lonnie joins: <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';"> <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Question 2 <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Q: Will FDA help with the bulk requests of DUNS numbers? <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">A (Lonnie): they have met with D&B and are waiting to hear from D&B with a plan. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">A: Virginia Hogan will follow up with D&B – meeting on Friday November 14. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';"> <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Question 3: <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Q:I understood we may use the NDC rather than the DUNS number. IS this the case? <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">A (Lonnie): What Randy (Dr. Levin) said – the FDA strongly prefers DUNS numbers not NDCs. Please use NDC as last resort.* <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';"> <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">* I have since spoken with Lonnie and he clarified with Randy that NDC numbers will be perfectly acceptable as opposed to DUNS numbers. – Virginia Hogan <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';"> <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Question 4 (not about DUNS number) <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Update of Facts@FDA <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Q: Will this be approved labeling? <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Open question <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';"> <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;"> <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Question 5: <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Q: What is the order of submitting the new SPL submissions? <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">A: Order of submissions <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">1. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">LCR – Labeler Code Request <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">2. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">ER – Electronic Site Registration <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">3. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">DL and CoL – Drug Listing and Content of Labeling <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';"> <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Virginia <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';"> described what occurred at the GPhA meeting in Bethesda, MD on October 28th. (All slides are available on the Generic Wiki page) <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Ann Vu presented a history of SPL. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Tom Marsden presented on the DUNS Numbers. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Lonnie Smith presented on SPL R4. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">There was a Q&A session with the FDA (Lonnie Smith, Randy Levin, Ann Vu and Koung Lee, monitored by Virginia Hogan.) The Questions and Answers will be posted to the Wiki. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Some highlights: <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: Arial;"> -  <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">D&B will work with Industry to put together a dedicated group to manage DUNS number requests. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: Arial;"> -  <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">D&B will not reuse DUNS numbers. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: Arial;"> -  <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">DUNS numbers are validated every 13 months <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: Arial;"> -  <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Randy announced the a site “Facts@FDA” will be set up & owned by the FDA. This will be a combination of the DailyMed and Drugs@FDA. This is a step toward the paperless labeling initiative. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: Arial;"> -  <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">You must use the gateway to submit. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: Arial;"> -  <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Only need to send in drug listing if labeling is changed. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: Arial;"> -  <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">X-Forms will be supported indefinitely. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: Arial;"> -  <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Industry – keep track of Marketing Dates that you have entered. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: Arial;"> -  <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">We need to be prepared – there is a huge amount of work. This is not just a pilot project, more of a transition – get your process together. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: Arial;"> -  <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Any chance the date will be moved out? Most likely not. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: Arial;"> -  <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">What if we are not ready? Who is in charge of waivers? Randy & Lonnie are in charge of waivers, but will not use them readily. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: Arial;"> -  <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Per Randy – “Begin Today!!!” <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: Arial;"> -  <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Talk to Lonnie if you have questions – he will gladly work one-on-one with your company. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: Arial;"> -  <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Join the HL7 SPL Working Groups. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';"> <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Jeffery described what occurred at the DIA meeting in Philadelphia, on October 29 th and 30 th. The Phillies won the World Series. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">As a minor point, Lonnie Smith presented and explained how to do <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Labeler Code Requests <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Establishment Registrations <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Vada Perkins filled in some holes and discussed CBER. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Michael Fauntleroy presented on the Electronic Submission Gateway that must be used for these submissions. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Tom Marsden presented on the DUNS Numbers. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">There was an extended question and answer period with the FDA and SPL group leads. The questions with their answers will be posted to the Wiki. All this occurred on the first day. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';"> <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">The second day, Gary Saner presented on some of the details of making the submissions happen including using some example files. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Jeffery Karp presented the Wiki and how to use it. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">The afternoon was devoted to demos/presentations from six of the vendors. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';"> <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif';">Attendees of this Generic Sub Team meeting on the following pages. <span style="font-size: 10pt; color: black; font-family: 'Arial','sans-serif'; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;"> ** Generic Sub Team Attendees  ** ** For Meeting 11/03/08  ** <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Generic Sub Team Leader || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> Virginia.Hogan@tevausa.com || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">OTC Team Coordinator <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Distribution only || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Consumer Healthcare Products Assoc. (CHPA) || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �550� �448��126��127��128��129� Karp, Jeffery <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Generics Sub Team Co Leader || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">RA/IT Associates || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> JMKarp01@comcast.net  || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Distribution list only || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">FDA || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> Lonnie.Smith@fda.hhs.gov  || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> ||
 * <span style="color: black; font-family: 'Calibri','sans-serif'; mso-bidi-font-family: Calibri;">Agenda - We will be discussing the GPhA and DIA SPL Workshops in Bethesda and Philadelphia that were held this past week. **
 * **<span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Name ** || **<span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Company ** || **<span style="font-size: 11pt; font-family: 'Helv','sans-serif';">E-mail ** ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Berger, Joan || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Image Solution || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �546� �403��14��15��16��17� Blik, Cheryl || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> Cheryl.Blik@tevausa.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Brandt, Richard || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">InVision Research || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> RBrandt@invisionresearch.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Cheng, Evelyn || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Global Respiratory Research, LLC || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �547� �412��38��39��40��41� Deborah Goff || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Sandoz || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> Deborah.Goff@sandoz.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Desai, Mona || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Par Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> Mona.Desai@parpharm.com  ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Edwards, Candis || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Amneal Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> CEdwards@Interpharminc.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Fariman, Denise || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Lannett Company, Inc. || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> DFairman@lannett.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Frahn, Jane + 3 team members || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> Jane.Frahn@tevausa.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Givens, Alycia || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Sandoz || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> Alycia.Givens@sandoz.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Halleran, Sue || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">West-ward Pharmaceutical Corp. || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �548� �433��94��95��96��97� Harvey, Mary || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Qualitest Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> MHarvey@qualitestrx.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Hewitt, Michele || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Sandoz || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �549� �439��110��111��112��113� Hogan, Virginia
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Howard, Marcia
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Kirkeleit-Davis, Jean || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Hospira || <span style="font-size: 11pt; font-family: �551� ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Kirkner, Ruth || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> Ruth.Kirkner@tevausa.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Klemick, Iva || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Amerigen Pharmaceuticals, Inc || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">IKlemick!AmerigenPharma.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Lavin, Marianne || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Parenteral Medicines || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> Marianne.Lavin@tevausa.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Lee, Koung || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">FDA, Office of Generic Drugs || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> Koung.Lee@fda.hhs.gov ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Nguyen, Wafa || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Qualitest Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> WNguyen@qualitestrx.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Nolder, Peggy || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Sandoz || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �552� �473��190��191��192��193� Patel, Shilpa || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Caraco Pharmaceutical Labs, Ltd. || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> Shilpa.Patel@caraco.com
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Peritore, Sal || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Barr Laboratories, Inc || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �553� �480��206��207��208��209� Roy, Mison || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Unichem || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �554� �483��214��215��216��217� Saner, Gary || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Reed Technology || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> GSaner@reedtech.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Santoro, Amanda || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Hospira || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv; mso-bidi-font-weight: bold;"> Amanda.Santoro@hospira.com <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Shieh, Betty || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> Betty.Shieh@tevausa.com
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Smith, Lonnie
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Strychar, Stefan || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �555� �500��254��255��256��257� Suknanan, Orin || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Sandoz || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> Orin.Suknanan@sandoz.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Tenaglia, Paul || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Apotex, Inc. || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Arial; mso-bidi-font-size: 10.0pt;"> PTenaglia@apotex.com
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Thibodeau, Wendy || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Sandoz || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> Wendy.Thibodeau@sandoz.com <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: 'Tms Rmn';">  <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Tidwell, Elizabeth || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Qualitest Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �556� �513��286��287��288��289� Troutman, Craig || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Intagras || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv; mso-bidi-font-size: 9.0pt;">CTrautman@intagras.com <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Wells, Hollie || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Sandoz || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> Hollie.Wells@sandoz.com <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: 'Tms Rmn';">  <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> ||