In July 2011, FDA began a pilot program to notify people of drug recalls before they are classified in an effort to expedite notifications of human drug product recalls to the public. FDA is now able to accomplish the goal of expedited notification within the Enforcement Report. These recalls are identified within the Enforcement Report by the label of “Not Yet Classified” in the “Classification” column. It is also possible to search the Enforcement Report for these “Not Yet Classified” recalls using the filter drop down menu. Therefore, as of September 15, 2017 FDA will discontinue the pilot program, and will no longer post drug recalls that are pending classification on this webpage. To see posted recalls that are pending classification go to the weekly Enforcement Report.
It appears that Sandoz and Upsher-Smith are currently approved to market generic oxandrin only for two very specific indications: (1) to offset protein catabolism associated with prolonged administration of corticosteroids and (2) for the relief of bone pain accompanying osteoporosis. Meanwhile, Barr Labs recently filed an ANDA to sell Oxandrin for all approved uses (and Savient responded by suing for patent infringement). The primary indication for Oxandrin is the promotion of weight gain following extensive surgery, chronic infection, or severe trauma. Oxandrin has annual sales of approximately $60 million.