[Federal Register: October 1, 2003 (Volume 68, Number 190)]
[Page 56636-56637]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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the four drug products listed in this document were not withdrawn from 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 Under FDA regulations, drugs are withdrawn from the list if the 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determines that the listed drug was withdrawn from sale for reasons of 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/
14-694            Hexadrol (dexamethasone     Organon, Inc., 375 Mt.
                   sodium phosphate)           Pleasant Ave., West
                   injection, 4 mg/mL and 10   Orange, NJ 07052
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]