[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Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or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withdrawn from sale for reasons of safety or effectiveness.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 Under FDA regulations, drugs are withdrawn from the list if the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determines that the listed drug was withdrawn from sale for reasons of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