[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and 20 Milliequivalents/Packet, Was Not Withdrawn From Sale for Reasons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packet, was not withdrawn from sale for reasons of safety or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drug was withdrawn from sale for reasons of safety or effectiveness (21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