[Federal Register Volume 65, Number 233 (Monday, December 4, 2000)]
[Notices]
[Pages 75717-75718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30773]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1639]


SangStat Medical Corp.; Withdrawal of Approval of an Abbreviated 
New Drug Application; Cyclosporine

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of an abbreviated new drug application (ANDA) held by SangStat Medical 
Corp., 6300 Dumbarton Circle, Fremont, CA 94555 (Sangstat). The ANDA is 
for SangCya Oral Solution (Cyclosporine Oral Solution, USP) Modified, 
which was the subject of a class II recall announced on July 10, 2000. 
SangStat has agreed in writing to

[[Page 75718]]

permit FDA to withdraw approval of the application and has waived its 
opportunity for a hearing.

EFFECTIVE DATES: January 3, 2001.

FOR FURTHER INFORMATION CONTACT: David T. Read, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: On July 10, 2000, SangCya Oral Solution 
(Cyclosporine Oral Solution, USP) Modified, 100 milligrams per 
milliliter, was the subject of a class II recall under 21 CFR part 7 
(Ref. 1). The recall of the drug product, marketed under ANDA 64-195, 
arose from data recently submitted by SangStat to the agency regarding 
the bioavailability of the product in healthy subjects when 
administered with apple juice. Following the recall, SangStat notified 
the agency in writing on July 21, 2000, that the company had decided to 
permanently withdraw the product from the market. On August 4, 2000, 
SangStat requested in writing that the agency withdraw approval of ANDA 
64-195. Subsequently, SangStat provided the agency with a full and 
complete waiver of the company's right to a hearing under section 
505(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
355(e)) to allow the agency to complete the withdrawal of approval 
under 21 CFR 314.150(d).
    Therefore, under section 505(e) of the act and under authority 
delegated to the Director, Center for Drug Evaluation and Research (21 
CFR 5.82), approval of ANDA 64-195, and all amendments and supplements 
thereto, is hereby withdrawn, effective January 3, 2001. The effective 
date of the withdrawal of approval is intended to allow patients the 
opportunity to complete their transition to another cyclosporine drug 
product (see Ref. 1). Thereafter, distribution of the product in 
interstate commerce without an approved application is illegal and 
subject to regulatory action. Also, on the basis of the circumstances 
described above that led to the recall of the product and its 
subsequent removal from the market, the agency will remove the product 
from the agency's list of drug products with effective approvals, 
published under the title ``Approved Drug Products with Therapeutic 
Equivalence Evaluations.'' This document serves as notice of the 
removal of the product covered by ANDA 64-195, SangCya Oral Solution, 
from the list of approved drug products.

Reference

    The following reference has been placed on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. The document may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
The document is available on the Internet at: http:www//fda.gov/bbs/topics/ANSWERS/ANS01025.html.
    1. FDA Talk Paper dated July 10, 2000.

    Dated: November 21, 2000.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 00-30773 Filed 12-1-00; 8:45 am]
BILLING CODE: 3510-22-S