If a product submits an application for a new product approval or substantial equivalence determination within the allotted 24-month period, it will not be taken off the market while the review of the application is pending.

Dr. Benowitz: "Dr. Benowitz, as a paid consultant for pharmaceutical companies, has assisted them with the design, development, and marketing of smoking-cessation products. Among the companies for which he has consulted on such products are GlaxoSmithKline plc and its affiliates (collectively, “GSK”); Pfizer, Inc. and its affiliates (collectively, “Pfizer”); Novartis AG and its affiliates (collectively, “Novartis”); Sanofi-Aventis U.S. LLC and its affiliates (collectively, “Sanofi-Aventis”); and Aradigm Corp. and its affiliates (collectively, “Aradigm”). During the last ten years, he has received at least approximately $10,000 per year for such consulting. He has also received grant support for research and writing from GSK and/or Pfizer on at least five occasions. In 2010, he co-authored a study, funded by Pfizer, on the use of its drug, Chantix, for smoking cessation."

C. Three

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