Rules and Regulations. Notice; correction
203 words·~1 min read·
/register/2002/12/23/02-32161·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 99N-1833] SoloPak Laboratories, Inc.; Withdrawal of Approval of 1 New Drug Application and 38 Abbreviated New Drug Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration
(FDA)is correcting a notice that appeared in the **Federal Register** of June 21, 1999 (64 FR 33097; corrected July 19, 1999 (64 FR 38675)). The document, which announced the withdrawal of approval of 1 new drug application
(NDA)and 38 abbeviated new drug applications held by SoloPak Laboratories, Inc., inadvertently withdrew approval of NDA 19-961 for Ganite (gallium nitrate). FDA has subsequently learned that SoloPak, at the time it requested withdrawal of this NDA, was not its holder. Therefore, SoloPak was not authorized to make such a request. FDA confirms that approval of NDA 19-961, currently held by Genta, Inc., is still in effect. DATES: Effective July 19, 1999. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Dated: November 25, 2002. Janet Woodcock, Director, Center for Drug Evaluation and Research. [FR Doc. 02-32161 Filed 12-20-02; 8:45 am]