[Federal Register Volume 65, Number 60 (Tuesday, March 28, 2000)]
[Notices]
[Pages 16396-16397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7542]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99P-4209]


Determination That Hydrocodone Bitartrate and Acetaminophen 
Tablets USP, 5 Milligrams/325 Milligrams, Were Not Withdrawn From Sale 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 
hydrocodone bitartrate and acetaminophen tablets USP, 5 milligrams 
(mg)/325 mg, were not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDA's) for this drug product.

FOR FURTHER INFORMATION CONTACT: David T. Read, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20855, 301-594-2041.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) (the 1984 amendments) 
authorizes the approval, under an abbreviated procedure, of duplicate 
versions of previously approved drug products. Sponsors of ANDA's do 
not have to repeat the extensive clinical testing necessary to gain 
approval of a new drug application (NDA). An ANDA sponsor must, with 
certain exceptions, show that the drug for which approval is sought 
contains the same active ingredient(s) in the same strength and dosage 
form as the ``listed drug,'' which is a version of the drug that was 
previously approved. 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 included 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 commonly referred to as the 
``Orange Book.'' Drugs are withdrawn from the list if the agency 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. 314.162 (21 CFR 314.162)). Also, before an ANDA that refers to a 
listed drug may be approved, the agency must determine whether the 
listed drug was withdrawn from sale for reasons of safety or 
effectiveness (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.
    Mallinckrodt, Inc., submitted a citizen petition dated September 
27, 1999 (Docket No. 99P-4209/CP1), under 21 CFR 10.30(b) and 
314.122(a), requesting that the agency determine whether hydrocodone 
bitartrate and acetaminophen tablets USP, 5 mg/325 mg, were withdrawn 
from sale for reasons of safety or effectiveness and, if not, to keep 
the drug in the Orange Book. Hydrocodone bitartrate and acetaminophen 
tablets USP, 5 mg/325 mg, are the subject of ANDA 40-099 held by UCB 
Pharma, Inc. ANDA 40-099 was approved on June 8, 1987, but the product 
was never marketed. FDA has determined, for purposes of Secs. 314.161 
and 314.162(c), that never marketing an approved drug product is 
equivalent to withdrawing the drug from sale.
    FDA has reviewed its records and, under Secs. 314.161 and 
314.162(c), has determined that hydrocodone bitartrate and 
acetaminophen tablets USP, 5 mg/325 mg, were not withdrawn from sale 
for reasons of safety or effectiveness. FDA will, therefore, continue 
to list this product in the Orange Book's ``Discontinued Drug Product 
List,'' which lists, among other items, drug products that have been 
discontinued from marketing for reasons other than safety or 
effectiveness. ANDA's that refer to hydrocodone bitartrate and 
acetaminophen tablets USP, 5 mg/325 mg, may be approved by the agency.


[[Page 16397]]


    Dated: March 20, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-7542 Filed 3-27-00; 8:45 am]
BILLING CODE 4160-01-F