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The President of the United States manages the operations of the Executive branch of Government through Executive orders. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications ANDAs that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application NDA. A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. We have also independently evaluated relevant literature and data for possible post marketing adverse events.

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