[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73599-73600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29034]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0320]


Determination That PFIZERPEN (Penicillin G Potassium) Injection, 
1 Million Units/Vial, Was Not Withdrawn From Sale for Reasons of Safety 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 
PFIZERPEN (penicillin G potassium) Injection, 1 million units/vial, was 
not withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for penicillin G potassium injection, 1 million 
units/vial, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products under an ANDA procedure. ANDA 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 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drug was withdrawn from sale for reasons of safety or effectiveness (21 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).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (21 CFR 314.161). FDA may not approve an ANDA that does not refer 
to a listed drug.
    PFIZERPEN (penicillin G potassium) Injection, 1 million units/vial, 
is the subject of ANDA 60-657, held by Pfizer, Inc., and initially 
approved on August 30, 1968. ANDA 60-657 is considered the designated 
reference standard. PFIZERPEN is indicated in the treatment of serious 
infections caused by susceptible strains of the designated 
microorganisms in certain conditions such as septicemia, pneumonia, 
meningitis, anthrax, and listeria.
    PFIZERPEN (penicillin G potassium) Injection, 1 million units/vial, 
is currently listed in the ``Discontinued Drug Product List'' section 
of the Orange Book. Lachman Consultant Services, Inc., submitted a 
citizen petition dated May 27, 2008 (Docket No. FDA-2008-P-0320), under 
21 CFR 10.30,

[[Page 73600]]

requesting that the Agency determine whether PFIZERPEN (penicillin G 
potassium) Injection, 1 units/vial, and penicillin G potassium 
injection, 1 million units/vial, had been withdrawn from sale for 
reasons of safety or effectiveness. Penicillin G potassium Injection, 1 
million units/vial, is the subject of ANDA 65-079, held by Sandoz, and 
approved on August 30, 2002.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that PFIZERPEN (penicillin G potassium) Injection, 
1 million units/vial, was not withdrawn for reasons of safety or 
effectiveness (this determination also applies to penicillin G 
potassium injection, 1 million units/vial, ANDA 65-079). The petitioner 
believes that PFIZERPEN (penicillin G potassium) Injection, 1 million 
units/vial, was not withdrawn for reasons of safety or effectiveness 
because it was discontinued due to commercial reasons. We have 
carefully reviewed our files for records concerning the withdrawal of 
PFIZERPEN (penicillin G potassium) Injection, 1 million units/vial, 
from sale. We have also independently evaluated relevant literature and 
data for possible postmarketing adverse events. We have reviewed the 
available evidence and determined that this product was not withdrawn 
from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list PFIZERPEN (penicillin 
G potassium) Injection, 1 million units/vial, 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 PFIZERPEN (penicillin G potassium) 
Injection, 1 million units/vial, 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: December 5, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29034 Filed 12-10-14; 8:45 am]
BILLING CODE 4164-01-P