[Federal Register Volume 69, Number 228 (Monday, November 29, 2004)]
[Notices]
[Pages 69373-69374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26271]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004P-0141]


Determination That 7.5% and 8.4% Sodium Bicarbonate Injection in 
Polyethylene Terephthalate Abboject Vials Were Not Withdrawn From Sale 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 
7.5% and 8.4% sodium bicarbonate injection in polyethylene 
terephthalate (PET) Abboject vials were not withdrawn from sale for 
reasons of safety or effectiveness. This determination will allow FDA 
to approve abbreviated new drug applications (ANDAs) for 7.5% and 8.4% 
sodium bicarbonate injection.

FOR FURTHER INFORMATION CONTACT: Nicole Mueller, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 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 abbreviated new drug 
application (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. Sponsors of ANDAs 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 generally known as the ``Orange 
Book.'' Under FDA regulations, drugs are withdrawn from the list if the

[[Page 69374]]

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)).
    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.
    The drug products 7.5% and 8.4% sodium bicarbonate injection in PET 
Abboject vials are the subject of approved NDA 19-443 held by Abbott 
Laboratories. The drug products 7.5% and 8.4% sodium bicarbonate 
injection in PET Abboject vials are indicated for the treatment of 
metabolic acidosis, certain drug overdosage, and severe diarrhea. The 
holder of the application for 7.5% and 8.4% sodium bicarbonate 
injection in PET Abboject vials requested a voluntary withdrawal and 
the marketing of the drug products was discontinued (61 FR 40649, 
August 5, 1996). In a citizen petition dated March 18, 2004 (Docket No. 
2004P-0141), submitted under 21 CFR 10.30 and 314.122, Abbott 
Laboratories requested that the agency determine whether 7.5% and 8.4% 
sodium bicarbonate injection in PET Abboject vials were withdrawn from 
sale for reasons of safety or effectiveness.
    The agency has determined that Abbott Laboratories' 7.5% and 8.4% 
sodium bicarbonate injection in PET Abboject vials were not withdrawn 
from sale for reasons of safety or effectiveness. FDA has independently 
evaluated relevant literature and data for possible postmarketing 
adverse event reports and has found no information that would indicate 
that these products were withdrawn for reasons of safety or 
effectiveness.
    For the reasons outlined, FDA determines that Abbott Laboratories' 
7.5% and 8.4% sodium bicarbonate injection in PET Abboject vials were 
not withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the agency will continue to list 7.5% and 8.4% sodium 
bicarbonate injection 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 7.5% and 8.4% sodium bicarbonate injection may be approved by 
the agency.

    Dated: November 18, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-26271 Filed 11-26-04; 8:45 am]
BILLING CODE 4160-01-S