
[Federal Register: October 5, 2010 (Volume 75, Number 192)]
[Notices]               
[Page 61503-61504]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05oc10-114]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-P-0338]

 
Determination That AZDONE (Hydrocodone Bitartrate and Aspirin) 
Tablet, 5 Milligrams/500 Milligrams, Was Not Withdrawn From Sale for 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 
AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 milligrams (mg)/
500 mg, was not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for hydrocodone bitartrate and aspirin 
tablet, 5 mg/500 mg, if all other legal and regulatory requirements are 
met.

FOR FURTHER INFORMATION CONTACT:  Deborah Livornese, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6306, Silver Spring, MD 20993-0002, 301-
796-0719.

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

[[Page 61504]]

applicants 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. ANDA applicants 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 known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are removed 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 (21 
CFR 314.162). Under Sec.  314.161(a)(1) (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.
    AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, is 
the subject of ANDA 89-420, held by Schwarz Pharma, Inc., and initially 
approved on January 25, 1988. AZDONE is indicated for the relief of 
moderate to moderately severe pain. AZDONE (hydrocodone bitartrate and 
aspirin) Tablet, 5 mg/500 mg is currently listed in the ``Discontinued 
Drug Product List'' section of the Orange Book.
    Lachman Consultant Services, Inc., submitted a citizen petition 
dated June 23, 2010 (Docket No. FDA-2010-P-0338), under 21 CFR 10.30, 
requesting that the Agency determine whether AZDONE (hydrocodone 
bitartrate and aspirin) Tablet, 5 mg/500 mg, was withdrawn from sale 
for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency 
records, FDA has determined under Sec.  314.161 that AZDONE 
(hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg was not 
withdrawn for reasons of safety or effectiveness. The petitioner has 
identified no data or other information suggesting that AZDONE 
(hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, was withdrawn 
for reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of AZDONE (hydrocodone 
bitartrate and aspirin) Tablet, 5 mg/500 mg, from sale. We have also 
independently evaluated relevant literature and data for possible 
postmarketing adverse events and have found no information that would 
indicate that this product was withdrawn from sale for reasons of 
safety or effectiveness. Accordingly, the Agency will continue to list 
AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 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 AZDONE (hydrocodone 
bitartrate and aspirin) Tablet, 5 mg/500 mg, may be approved by the 
Agency as long as they meet all other legal and regulatory requirements 
for the 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: September 29, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-24902 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S

