[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61503-61504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24902]
-----------------------------------------------------------------------
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Tablet, 5 Milligrams/500 Milligrams, Was Not Withdrawn From Sale for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.
-----------------------------------------------------------------------
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500 mg, was not withdrawn from sale for reasons of safety or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