[Federal Register: October 1, 2003 (Volume 68, Number 190)]
[Notices]
[Page 56636-56637]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01oc03-71]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0421]
Determination That Trilafon Tablets and Three Other Drug Products
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined that
the four drug products listed in this document were not withdrawn from
sale for reasons of safety or effectiveness. These are drug products
with approved new drug applications (NDAs) to which one or more
approved abbreviated new drug applications (ANDAs) refer. This
determination means that the approval status of the ANDAs is unaffected
by the withdrawal from sale of the reference product.
FOR FURTHER INFORMATION CONTACT: Mary Catchings, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20855, 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 an 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 Under FDA regulations, drugs are withdrawn from the list if the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
[[Page 56637]]
determines that the listed drug was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
If a listed drug is withdrawn from sale and there are approved
ANDAs that refer to that drug, under Sec. 314.161(a)(2) (21 CFR
314.161(a)(2)), the agency must determine whether the listed drug was
withdrawn from sale for reasons of safety or effectiveness. Section
314.161(d) provides that if FDA determines that the listed drug was
removed from sale for safety or effectiveness reasons, the agency will
initiate proceedings that could result in the withdrawal of approval of
the ANDAs that refer to the listed drug.
The holders of the applications listed in the table in this
document have informed FDA that the drug products have been withdrawn
from sale. The drug products in the table are subjects of approved NDAs
to which one or more approved ANDAs refer.
------------------------------------------------------------------------
NDA No. Drug Applicant
------------------------------------------------------------------------
10-775 Trilafon (perphenazine) Schering Corp., 2000
tablets, 2, 4, 8, and 16 Galloping Hill Rd.,
milligrams (mg) Kenilworth, NJ 07033
12-071 Decadron (dexamethasone Merck & Co., P.O. Box 4,
sodium phosphate) West Point, GA 19486-0004
injection, 4 mg/
milliliter (mL) and 24 mg/
mL
14-694 Hexadrol (dexamethasone Organon, Inc., 375 Mt.
sodium phosphate) Pleasant Ave., West
injection, 4 mg/mL and 10 Orange, NJ 07052
mg/mL
19-304 Tricor (fenofibrate) Abbott Laboratories, 200
capsules, 67, 134, and Abbott Park Rd., Abbott
200 mg Park, IL 60064-3537
------------------------------------------------------------------------
FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness. Approved
ANDAs that refer to the NDAs listed in this document are unaffected by
the withdrawal of these products subject to those NDAs, and
accordingly, the agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
Dated: September 17, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-24862 Filed 9-30-03; 8:45 am]
BILLING CODE 4160-01-S