[Federal Register Volume 68, Number 222 (Tuesday, November 18, 2003)]
[Notices]
[Pages 65074-65075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28742]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003P-0300]


Determination That Diclofenac Potassium 25-Milligram Tablet 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Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 diclofenac potassium 25-milligram (mg) tablet 
(Cataflam) was not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for diclofenac potassium 25-mg tablet.

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

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 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 ANDAs 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 include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), 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 Under FDA regulations, drugs are withdrawn from the list if the 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 Sec.  314.62 (21 CFR 314.162)). Regulations also provide 
that the agency must determine 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 (Sec.  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 June 27, 2003, The Weinberg Group, Inc., submitted a citizen 
petition (Docket No. 2003P-0300/CP1) under 21 CFR 10.30 to FDA 
requesting that the agency determine whether diclofenac potassium 25-mg 
tablet was withdrawn from sale for reasons of safety or effectiveness. 
Diclofenac potassium 25-mg tablet is the subject of NDA 20-142, 
approved in 1993 and held by Novartis Pharmaceuticals Corp. (Novartis). 
Diclofenac potassium is used for the treatment of osteoarthritis and 
rheumatoid arthritis. FDA has determined that shortly after the 
approval of NDA 20-142, Novartis made the decision not to market 
diclofenac potassium 25-mg tablet in the United States. It was moved 
from the prescription drug product list to the ``Discontinued Drug 
Product List'' section of the Orange Book. FDA has determined that, for 
purposes of Sec. Sec.  314.161 and 314.162, never marketing an approved 
drug product is

[[Page 65075]]

equivalent to withdrawing the drug from sale.
    FDA has reviewed its records and, under Sec.  314.161, has 
determined that diclofenac potassium 25-mg tablet was not withdrawn 
from sale for reasons of safety or effectiveness. Accordingly, the 
agency will continue to list diclofenac potassium 25-mg tablet in 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. ANDAs that refer to diclofenac potassium 
25-mg tablet may be approved by the agency.

    Dated: November 8, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-28742 Filed 11-17-03; 8:45 am]
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