[Federal Register Volume 61, Number 98 (Monday, May 20, 1996)]
[Notices]
[Pages 25228-25229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12570]



-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0151]


SmithKline Beecham Pharmaceuticals; Withdrawal of Approval of a 
New Drug Application for Selacryn Tablets

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new drug application (NDA) for Selacryn (ticrynafen) 
Tablets held by SmithKline Beecham Pharmaceuticals (Smithkline). 
SmithKline requested that the NDA be withdrawn because the product is 
no longer being marketed. SmithKline also waived its opportunity for a 
hearing.

EFFECTIVE DATE: May 20, 1996.

FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1038.

SUPPLEMENTARY INFORMATION: By letter dated June 30, 1994, SmithKline, 
Four Falls Corp. Center, Route 23 and Woodmont Ave., P.O. Box 1510, 
FF0410, King of Prussia, PA 19406, requested that FDA withdraw NDA 18-
103 for Selacryn (ticrynafen) Tablets, stating that the 
company discontinued

[[Page 25229]]

marketing the product in 1980 because of liver toxicity observed after 
approval of the NDA. SmithKline waived its opportunity for a hearing.
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the 
Director, Center for Drug Evaluation and Research (21 CFR 5.82), 
approval of NDA 18-103, and all amendments and supplements thereto, is 
hereby withdrawn effective May 20, 1996.

    Dated: May 6, 1996.
Murray M. Lumpkin,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 96-12570 Filed 5-15-96; 8:45 am]
BILLING CODE 4160-01-F