[Federal Register Volume 72, Number 156 (Tuesday, August 14, 2007)]
[Notices]
[Pages 45434-45435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15843]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006P-0281]


Determination That ORUDIS KT (Ketoprofen) Tablets, 12.5 
Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or 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) has determined that 
ORUDIS KT (ketoprofen) tablets, 12.5 milligrams (mg), were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for ketoprofen tablets, 12.5 mg.

FOR FURTHER INFORMATION CONTACT: Mary 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 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. Sponsors of ANDAs do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (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 Under FDA regulations, drugs are withdrawn from the list if the 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

[[Page 45435]]

determines that the listed drug was withdrawn from sale for reasons of 
safety or effectiveness (21 CFR 314.162).
    Under 21 CFR 314.161(a)(1), 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. FDA may not approve an ANDA that does not refer to a listed 
drug.
    In a citizen petition dated July 11, 2006 (Docket No. 2006P-0281/
CP1), submitted under 21 CFR 10.30, Camargo Pharmaceutical Services, 
LLC, requested that the agency determine whether ORUDIS KT (ketoprofen) 
tablets, 12.5 mg, were withdrawn from sale for reasons of safety or 
effectiveness. ORUDIS KT (ketoprofen) tablets, 12.5 mg, are the subject 
of approved NDA 20-429 held by Wyeth Consumer Healthcare (Wyeth). 
ORUDIS KT, an over-the-counter nonsteroidal anti-inflammatory (NSAID) 
drug indicated for the temporary relief of minor aches and pains 
associated with the common cold, headache, toothache, muscular aches, 
backache, minor pain of arthritis and menstrual cramps. ORUDIS KT 
(ketoprofen) is also indicated to temporarily reduce fever. In a letter 
dated August 24, 2005, Wyeth informed FDA of the firm's decision to 
discontinue manufacture of ORUDIS KT (ketoprofen) tablets, 12.5 mg, and 
the product was moved to the ``Discontinued Drug Product List'' section 
of the Orange Book.
    The agency has determined that ORUDIS KT (ketoprofen) tablets, 12.5 
mg, were not withdrawn from sale for reasons of safety or 
effectiveness. The petitioner referenced, among other information, 
certain labeling changes intended to assist consumers in the safe use 
of the drug, and some adverse event reports. FDA has independently 
evaluated relevant literature and data for possible postmarketing 
adverse events and has determined that this product was not withdrawn 
from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing agency 
records, FDA determines that, for the reasons outlined in this notice, 
ORUDIS KT (ketoprofen) tablets, 12.5 mg, were not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the agency will 
continue to list ORUDIS KT (ketoprofen) tablets, 12.5 mg, 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 ORUDIS KT 
(ketoprofen) tablets, 12.5 mg, may be approved by the agency as long as 
they meet all relevant legal and regulatory requirements for approval 
of ANDAs. If FDA determines that labeling for this drug product should 
be revised to meet current standards, the agency will advise ANDA 
applicants to submit such labeling.

    Dated: August 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-15843 Filed 8-13-07; 8:45 am]
BILLING CODE 4160-01-S