[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63228-63229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-24780]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-0503]


Determination That Potassium Citrate, 10 Milliequivalents/Packet 
and 20 Milliequivalents/Packet, Was Not Withdrawn From Sale for Reasons 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 
Potassium Citrate, 10 milliequivalents/packet (mEq/packet) and 20 mEq/
packet, was not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for Potassium Citrate, 10 mEq/packet and 
20 mEq/packet, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Linda Jong, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, rm. 6224, Silver Spring, MD 20993-0002, 301-796-3977.

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

[[Page 63229]]

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 (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    Potassium Citrate, 10 mEq/packet and 20 mEq/packet, is the subject 
of NDA 19-647, held by Nova-K LLC, and initially approved on October 
13, 1988. Potassium Citrate is indicated for the management of renal 
tubular acidosis with calcium stones, hypocitraturic calcium oxalate 
nephrolithiasis of any etiology, and uric acid lithiasis with or 
without calcium stones.
    Potassium Citrate, 10 mEq/packet and 20 mEq/packet, is currently 
listed in the ``Discontinued Drug Product List'' section of the Orange 
Book. Nomax, Inc., submitted a citizen petition dated April 18, 2013 
(Docket No. FDA-2013-P-0503), under 21 CFR 10.30, requesting that the 
Agency determine whether Potassium Citrate, 10 mEq/packet and 20 mEq/
packet, was withdrawn from sale for reasons of safety or effectiveness.
    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 Potassium Citrate, 10 mEq/packet 
and 20 mEq/packet, was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that Potassium Citrate, 10 mEq/packet and 20 
mEq/packet, was withdrawn for reasons of safety or effectiveness. We 
have carefully reviewed our files for records concerning the withdrawal 
of Potassium Citrate, 10 mEq/packet and 20 mEq/packet, from sale. We 
have also independently evaluated relevant literature and data for 
possible postmarketing adverse events. We 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 Potassium Citrate, 10 
mEq/packet and 20 mEq/packet, 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 Potassium Citrate, 10 mEq/packet and 
20 mEq/packet, 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: October 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24780 Filed 10-22-13; 8:45 am]
BILLING CODE 4160-01-P