[Federal Register Volume 63, Number 192 (Monday, October 5, 1998)]
[Notices]
[Page 53444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26522]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96N-0512]


Hoechst Marion Roussel, Inc., and Baker Norton Pharmaceuticals, 
Inc.; Terfenadine; Withdrawal of Approval of Two New Drug Applications 
and One Abbreviated New Drug Application

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is withdrawing 
approval of two new drug applications (NDA's) and one abbreviated new 
drug application (ANDA) for drug products containing terfenadine. NDA 
18-949 (Seldane) and NDA 19-664 (Seldane-D) are held by Hoechst Marion 
Roussel, Inc. (HMR), 10236 Marion Park Dr., Kansas City, MO 64134. ANDA 
74-475 is held by Baker Norton Pharmaceuticals, Inc. (Baker Norton), 
4400 Biscayne Blvd., Miami, FL 33137. The basis for the action is a 
finding that terfenadine is not shown to be safe for use in the 
treatment of seasonal allergic rhinitis. HMR and Baker Norton waived 
their opportunity for a hearing. No other party has requested a 
hearing.

EFFECTIVE DATE: November 4, 1998.

FOR FURTHER INFORMATION CONTACT: Andrea C. Masciale, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5648.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of January 14, 1997 (62 FR 1889), the Director of FDA's Center 
for Drug Evaluation and Research (the Director) offered an opportunity 
for a hearing on a proposal to issue an order under section 505(e) of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)) 
withdrawing approval of NDA 18-949 and NDA 19-664, and all amendments 
and supplements thereto, and under section 505(j) of the act, 
withdrawing approval of ANDA 74-475, and all amendments and supplements 
thereto. The Director based the proposed action on: (1) A finding that 
new evidence of clinical experience, not contained in NDA 18-949 and 
NDA 19-664 or not available to the Director until after the 
applications were approved, evaluated together with the evidence 
available to the Director when the applications were approved, 
demonstrates that terfenadine is not shown to be safe for use under the 
conditions of use that formed the basis upon which the applications 
were approved; and (2) a finding that ANDA 74-475 refers to NDA 18-949 
as the listed drug. HMR requested a hearing on the proposed action by 
letter dated February 11, 1997, and Baker Norton requested a hearing by 
letter dated February 12, 1997. Subsequently, HMR and Baker Norton, by 
letters dated June 30, 1998, and July 9, 1998, respectively, withdrew 
their hearing requests and waived their opportunity for a hearing. No 
other party filed a request for a hearing within the 30 days following 
publication of the notice in the Federal Register.
    Accordingly, for the reasons discussed in the notice, the Director, 
under section 505(e) of the act and under authority delegated to her 
(21 CFR 5.82), finds that new evidence of clinical experience not 
contained in the applications for Seldane and Seldane-D and not 
available at the time of approval, evaluated together with the evidence 
available at the time the applications were approved, shows that 
terfenadine is not shown to be safe for use under the conditions of use 
that formed the basis upon which the applications were approved (21 
U.S.C. 355(e)(2)). Therefore, approval of NDA 18-949 and NDA 19-664, is 
hereby withdrawn, effective November 4, 1998. Furthermore, the Director 
finds that ANDA 74-475 refers to the drug that is the subject of NDA 
18-949 (Seldane, 60-milligram terfenadine oral tablets). Therefore, 
under section 505(j) of the act, the approval of ANDA 74-475 is also 
withdrawn, effective November 4, 1998.
    Under 21 CFR 314.161 and 314.162(a)(1), the products containing 
terfenadine named previously will be removed from the list of drug 
products with effective approvals published in FDA's publication 
entitled ``Approved Drug Products with Therapeutic Equivalence 
Evaluations.'' FDA will not approve or accept ANDA's that refer to 
these drug products.

    Dated: September 14, 1998.
 Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 98-26522 Filed 10-2-98; 8:45 am]
BILLING CODE 4160-01-F