[Federal Register Volume 67, Number 246 (Monday, December 23, 2002)]
[Notices]
[Page 78235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32161]


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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.

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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]
BILLING CODE 4160-01-S