Medical Letter on the CDC & FDA
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Generic Drugs
Citizens' petition filed with U.S. FDA on generic oral oxandrolone products
October 23rd, 2005
Savient Pharmaceuticals, Inc. (SVNTE) a pharmaceuticals company developing, therapeutic products, announced it has filed a Citizens' Petition with the U.S. Food and Drug Administration (FDA) requesting that the commissioner of Food and Drugs not approve any Abbreviated New Drug Application (ANDA) for generic oral products containing oxandrolone prior to the expiration of the company's exclusive labeling for geriatric dosing on June 20, 2008. The FDA's guidance on geriatric labeling requires that ANDA's contain the same geriatric labeling as the reference listed drug (RLD). In 1997, the agency established specific requirements for the labeling of...
Source: Medical Letter on the CDC & FDA (2005-10-23)
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