
[Federal Register Volume 79, Number 115 (Monday, June 16, 2014)]
[Notices]
[Pages 34313-34314]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13906]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-1654]


Determination That LEUCOVORIN CALCIUM-PRESERVATIVE FREE 
Injection, 10 Milligrams/1 Milliliter, 10 Milliliter Total Fill Volume, 
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 
LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 milligrams (mg)/1 
milliliter (mL), 10 mL total fill volume, was not withdrawn from sale 
for reasons of safety or effectiveness. This determination will allow 
FDA to approve abbreviated new drug applications (ANDAs) for LEUCOVORIN 
CALCIUM-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill 
volume, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Darren Eicken, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240-
402-0978.

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 (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL 
total fill volume, is the subject of ANDA 40147, held by Hospira, Inc. 
(Hospira), and was initially approved on June 25, 1997. LEUCOVORIN 
CALCIUM-

[[Page 34314]]

PRESERVATIVE FREE is indicated for treatment of megaloblastic anemia 
and to counteract the therapeutic and toxic effects of folic acid 
antagonists.
    In a letter dated January 14, 2005, Hospira notified FDA that 
LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total 
fill volume, was being discontinued, and FDA moved the drug product to 
the ``Discontinued Drug Product List'' section of the Orange Book.
    Gordon Johnston, on behalf of Gordon Johnston Regulatory 
Consultants, LLC, submitted a citizen petition dated December 13, 2013 
(Docket No. FDA-2013-P-1654), under 21 CFR 10.30, requesting that the 
Agency determine whether LEUCOVORIN CALCIUM-PRESERVATIVE FREE 
Injection, 10 mg/1 mL, 10 mL total fill volume, 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 LEUCOVORIN CALCIUM-PRESERVATIVE FREE 
Injection, 10 mg/1 mL, 10 mL total fill volume, was not withdrawn for 
reasons of safety or effectiveness. The petitioner has identified no 
data or other information suggesting that LEUCOVORIN CALCIUM-
PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill volume, was 
withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of LEUCOVORIN 
CALCIUM-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill 
volume, 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 LEUCOVORIN CALCIUM-
PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill volume, 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 LEUCOVORIN CALCIUM-
PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill volume, 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: June 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13906 Filed 6-13-14; 8:45 am]
BILLING CODE 4164-01-P


