[Federal Register Volume 63, Number 201 (Monday, October 19, 1998)]
[Notices]
[Page 55873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27889]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98P-0086]


Determination That Sutilains Ointment USP Was Not Withdrawn From 
Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
determination that sutilains ointment USP (Travase Ointment) 
was not withdrawn from sale for reasons of safety or effectiveness. 
This determination will allow FDA to approve abbreviated new drug 
applications (ANDA's) for sutilains ointment USP.

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 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
sponsors must, with certain exceptions, show that the drug for which 
they are seeking approval contains the same active ingredient in the 
same strength and dosage form as the ``listed drug,'' which is a 
version of the drug that was previously approved under a new drug 
application (NDA). Sponsors of ANDA's do not have to repeat the 
extensive clinical testing otherwise necessary to gain approval of an 
NDA. The only clinical data required in an ANDA are data to show that 
the drug that is the subject of the ANDA is bioequivalent to the listed 
drug.
    The 1984 amendments included what is now section 505(j)(6) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(6)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products with Therapeutic 
Equivalence Evaluations,'' which is generally known as the ``Orange 
Book.'' Under FDA regulations, drugs are withdrawn from the list if the 
agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness, or if FDA determines that the 
listed drug was withdrawn from sale for reasons of safety or 
effectiveness (21 CFR 314.162). Regulations also provide that the 
agency must make a determination as to whether a listed drug was 
withdrawn from sale for reasons of safety or effectiveness before an 
ANDA that refers to that listed drug may be approved (314.161(a)(1) (21 
CFR 314.161(a)(1))). FDA may not approve an ANDA that does not refer to 
a listed drug.
    On February 11, 1998, Hogan & Hartson, L.L.P. submitted a citizen 
petition (Docket No. 98P-0086/CP1) under 21 CFR 10.30 to FDA requesting 
that the agency determine whether sutilains ointment USP was withdrawn 
from sale for reasons of safety or effectiveness. Sutilains ointment 
USP (Travase Ointment) is the subject of NDA 12-828. FDA 
approved NDA 12-828, held by Travenol Laboratories, on June 12, 1969. 
The right to market sutilains ointment USP was subsequently transferred 
to Boots Pharmaceuticals, Inc., which became part of Knoll 
Pharmaceuticals (Knoll) on April 1, 1995. Knoll stopped distribution of 
the drug product effective March 29, 1996.
    FDA has reviewed its records and, under Sec. 314.161, has 
determined that Knoll's decision not to market sutilains ointment USP 
was not for reasons of safety or effectiveness. Accordingly, the agency 
will move sutilains ointment USP to the ``Discontinued Drug Product 
List'' section of the Orange Book. The ``Discontinued Drug Product 
List'' delineates, among other items, drug products that have been 
discontinued from marketing for reasons other than safety or 
effectiveness. ANDA's that refer to sutilains ointment USP may be 
approved by the agency.

    Dated: October 9, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-27889 Filed 10-16-98; 8:45 am]
BILLING CODE 4160-01-F