[Federal Register Volume 63, Number 200 (Friday, October 16, 1998)]
[Notices]
[Pages 55616-55617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27739]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 77N-0240]


Erythrityl Tetranitrate; Drug Efficacy Study Implementation; 
Withdrawal of Approval of Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing 
conditional approval of abbreviated new drug applications (ANDA's) for 
single-entity drug products containing erythrityl tetranitrate. FDA is 
withdrawing approval because there is a lack of substantial evidence 
that these drugs are effective for indications relating to the 
management, prophylaxis, or treatment of anginal attacks.

EFFECTIVE DATE: November 16, 1998.

ADDRESSES: Requests for an opinion on the applicability of this notice 
to a specific product should be identified with Docket No. 77N-0240 and 
reference number DESI 1786 and directed to the Division of Prescription 
Drug Compliance and Surveillance (HFD-330), Center for Drug Evaluation 
and Research, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855.

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

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of June 23, 1998 (63 FR 34188), FDA revoked the temporary 
exemption for the drug products described in this document which 
permitted these products to remain on the market beyond the time limits 
scheduled for implementation of the Drug Efficacy Study. The notice 
also offered an opportunity to request a hearing on a proposal to 
withdraw approval of the conditionally approved new drug applications 
for these products insofar as they provide for indications relating

[[Page 55617]]

to the management, prophylaxis, or treatment of anginal attacks. The 
proposal was based on a lack of substantial evidence of effectiveness 
as required by section 505(e) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 355(e)) and 21 CFR 314.126.
    Neither the holder of the conditionally approved ANDA's nor any 
other person filed a written notice of appearance and request for 
hearing as provided by the notice (63 FR 34188). The failure to file 
such an appearance and request for hearing constitutes a waiver of the 
opportunity for hearing. Accordingly, approval of the following 
conditionally approved ANDA's is being withdrawn:
    1. ANDA 86-194; Cardilate Chewable Tablets containing 10 milligrams 
(mg) erythrityl tetranitrate per tablet; Glaxo Wellcome (formerly 
Burroughs Wellcome), 3030 Cornwallis Rd., P.O. Box 12700, Research 
Triangle Park, NC 27709-2700.
    2. ANDA 86-203; Cardilate Tablets containing 5, 10, or 15 mg of 
erythrityl tetranitrate per tablet; Glaxo Wellcome.
    Although FDA withdrew approval of ANDA 86-194 in the Federal 
Register of February 13, 1996 (61 FR 5563), based on the applicant's 
written request, this notice constitutes FDA's final conclusions on the 
effectiveness of the product.
    Any drug product that is identical, related, or similar to the drug 
products named previously and is not the subject of an approved new 
drug application is covered by the applications listed previously and 
is subject to this notice (21 CFR 310.6). Any person who wishes to 
determine whether a specific product is covered by this notice should 
write to the Division of Prescription Drug Compliance and Surveillance 
(address above).
    The Director of the Center for Drug Evaluation and Research, under 
section 505 of the act and under authority delegated to her (21 CFR 
5.82), finds that, on the basis of new information on the drugs and the 
evidence available when the applications were approved, there is a lack 
of substantial evidence that the products named previously will have 
the effects they purport or are represented to have under the 
conditions of use prescribed, recommended, or suggested in their 
labeling.
    Therefore, based on the foregoing finding, approval of ANDA's 86-
194 and 86-203 and all their amendments and supplements are withdrawn 
effective November 16, 1998. Shipment in interstate commerce of these 
products or of any identical, related, or similar product that is not 
the subject of a fully approved new drug application will then be 
unlawful.

    Dated: September 25, 1998.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 98-27739 Filed 10-15-98; 8:45 am]
BILLING CODE 4160-01-F