Breaking News

FDA Roundup: December 6, 2022 Lilly Announces Updated Data from the Verzenio® (abemaciclib) Phase 3 monarchE Trial Presented at SABCS and Simultaneously Published in The Lancet Oncology Statement by Assistant Secretary for Mine Safety and Health Williamson recognizing America’s mine workers on National Miners Day Daily Press Briefing by the Office of the Spokesperson for the Secretary-General Wellesley Island Border Patrol Agents and the Jefferson County Sheriff’s Office Seized Approximately 150 Pounds of Marijuana Governor Cooper Announces Alamance Foods Will Expand and Create 135 Jobs FEMA Awards Almost $4.5 Million to Manchester-by-the-Sea to Fight Flooding Readout of Deputy Secretary of Defense Dr. Kathleen H. Hicks’ Meeting With U.K. Permanent Under Secretary of Defence David Williams

Issued: Research Triangle Park, NC and London, UK

GlaxoSmithKline (GSK) has agreed to pay $40.75 million, which will be divided among 37 states and the District of Columbia, as part of an agreement reached related to events during the early 2000s at its former manufacturing facility in Cidra, Puerto Rico.  

The company chose to settle the matter, which it initially disclosed in its 2010 fourth quarter results and its 2010 annual report, to avoid the expense and uncertainty of protracted litigation and trial. The company did not admit to any wrongdoing or liability of any kind under these states’ consumer protection laws in this settlement.  

In 2009, GSK closed the plant because of declining demand for the medicines made there. GSK sold the facility in 2010. Prior to selling the facility, brought it into compliance and to a high level of performance that satisfied both GSK and the FDA.  

GSK’s manufacturing division has a strong track record of quality and compliance with current Good Manufacturing Practice (cGMP) requirements. Various regulatory agencies – including the FDA – conduct an average of more than 100 inspections each year at over 80 GSK manufacturing sites located in over 30 countries. The FDA has raised no material issues as a result of its very thorough inspections.  

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

GlaxoSmithKline Enquiries:

UK Media enquiries David Mawdsley (020) 8047 5502
  Stephen Rea (020) 8047 5502
  Sarah Spencer (020) 8047 5502
  Janet Morgan (020) 8047 5502
  David Daley (020) 8047 5502
US Media enquiries Nancy Pekarek (919) 483 2839
  Mary Anne Rhyne (919) 483 2839
  Kevin Colgan (919) 483 2839
  Sarah Alspach (919) 483 2839
European Analyst / Investor enquiries Sally Ferguson (020) 8047 5543
  Gary Davies (020) 8047 5503
  Ziba Shamsi (020) 8047 3289
US Analyst / Investor enquiries Tom Curry (215) 751 5419
  Jeff McLaughlin (215) 751 7002​

 

GlaxoSmithKline cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’s operations are described under ‘Risk Factors’ in the ‘Business Review’ in the company’s Annual Report on Form 20-F for 2010.

Source link