SoloPak Laboratories, Inc.; Withdrawal of Approval of 1 New Drug Application and 38 Abbreviated New Drug Applications; Correction

[Federal Register Volume 64, Number 137 (Monday, July 19, 1999)]
[Notices]
[Page 38675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18235]


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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). 
The document announced the withdrawal of approval of 1 new drug 
application (NDA) and 38 abbreviated new drug applications (ANDA's) 
held by SoloPak Laboratories, Inc. The document omitted language 
explaining that the sponsor voluntarily removed the products from the 
market because of discrepancies concerning the data submitted to 
support continued approval of the applications. This document corrects 
that omission.

EFFECTIVE DATE: July 19, 1999.
FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

    In FR Doc. 99-15581, appearing on page 33097 in the Federal 
Register of Monday, June 21, 1999, the following correction is made: 
Onpage 33098, immediately preceding the table, add the following two 
paragraphs to read as follows:
    Recently, FDA became aware of discrepancies concerning the data 
submitted to support continued approval of the following ANDA's held by 
SoloPak:
    ANDA 88-457; Heparin Lock Flush Solution USP, 10 units/milliliter 
(mL); and
    ANDA 88-519; Phenytoin Sodium Injection USP, 50 milligrams (mg)/mL.
    After careful review of inspectional findings, the agency 
determined that there was sufficient justification to initiate 
proceedings to withdraw approval of the two products listed above. 
SoloPak was notified in writing of the determinations and, in 
accordance with Sec. 314.150(d) (21 CFR 314.150(d)), was offered an 
opportunity to permit FDA to withdraw the applications. Subsequently, 
in letters dated December 15, 1998, and March 31, 1999, SoloPak 
requested withdrawal under Sec. 314.150(d) of the applications listed 
in the following table, thereby waiving its opportunity for a hearing.

    Dated: July 8, 1999.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 99-18235 Filed 7-16-99; 8:45 am]
BILLING CODE 4160-01-F