FDA Webview
X

Free FDA Notices

FDA Corrects Withdrawn NADA

03/31/2014

Federal Register Final rule: FDA is correcting a document amending the animal drug regulations to reflect the withdrawal of approval of NADAs that appeared in 2/27 Federal Register (79 FR 10976). That document listed an NADA for which a withdrawal of approval (WOA) was not intended and failed to remove all conditions of use associated with the withdrawn NADAs. On page 10976, in the second column, in the 4th line of the “SUMMARY” section, remove “69” and replace with “68”. On page 10977, appearing near the end of the page, “Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria, has requested that FDA withdraw approval of the following 16 NADAs and 8 ANADAs”, is corrected to read “Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria, has requested that FDA withdraw approval of the following 15 NADAs and 8 ANADAs”; and on the same page in the table, the entry “013-461 3-NITRO (roxarsone)/AMPROL Plus (amprolium and ethopabate)” is removed. To view this final rule, click here.

LATEST NEWS