Document ID: FDA-2014-P-1896-0005
Agency: fda
Document Type: Notice
Title: Determination That OXYTOCIN in 5% Dextrose Injection Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Posted Date: 2015-04-22T04:00Z

[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Page 22529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09299]

[[Page 22529]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-P-1896]

Determination That OXYTOCIN in 5% Dextrose Injection Products 
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 or Agency) has 
determined that OXYTOCIN 5 United States Pharmacopeia (USP) Units in 
Dextrose 5% (oxytocin), injectable, injection, 5 USP Units in 500 
milliliters (mL), (1 USP Unit/100 mL); OXYTOCIN 10 USP Units in 
Dextrose 5% (oxytocin), injectable, injection, 10 USP Units in 500 mL, 
(2 USP Units/100 mL); OXYTOCIN 10 USP Units in Dextrose 5% (oxytocin), 
injectable, injection, 10 USP Units in 1000 mL, (1 USP Unit/100 mL); 
and OXYTOCIN 20 USP Units in Dextrose 5% (oxytocin), injectable, 
injection, 20 USP Units in 1000 mL, (2 USP Units/100 mL), (hereinafter 
``these oxytocin drug products'') were not withdrawn from sale for 
reasons of safety or effectiveness. This determination will allow FDA 
to approve an abbreviated new drug application (ANDA) for these 
oxytocin drug products, if all other legal and regulatory requirements 
are met.

FOR FURTHER INFORMATION CONTACT: Robin Fastenau, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 240-
402-4510.

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.
    These oxytocin drug products are the subject of NDA 019-185, held 
by Abbott Laboratories, and initially approved on March 29, 1985. These 
oxytocin drug products are indicated for the initiation or improvement 
of uterine contractions. In a December 26, 1995, letter, Abbott 
Laboratories notified FDA that these oxytocin drug products were being 
discontinued and requested withdrawal of NDA 019-185. In the Federal 
Register of March 27, 1996 (61 FR 13506), FDA announced that it was 
withdrawing approval of NDA 019-185, effective April 26, 1996. FDA has 
moved these oxytocin drug products to the ``Discontinued Drug Product 
List'' section of the Orange Book.
    TechReg Services, Inc. (TechReg), submitted a citizen petition 
dated November 12, 2014 (Docket No. FDA-2014-P-1896), under 21 CFR 
10.30, requesting that the Agency determine whether Oxytocin in 
Dextrose 5%, injection, available as strengths 5, 10, and 20 units 
under Abbott NDA 019-185, were withdrawn from sale for reasons of 
safety or effectiveness. Although the citizen petition did not specify 
the concentrations of the three strengths associated with NDA 019-185, 
we have considered whether any of these oxytocin drug products approved 
under NDA 019-185 were withdrawn for safety or effectiveness reasons.
    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 these oxytocin drug products were 
not withdrawn for reasons of safety or effectiveness. TechReg has 
identified no data or other information suggesting that these oxytocin 
drug products were withdrawn for reasons of safety or effectiveness. We 
have carefully reviewed our files for records concerning the withdrawal 
of these oxytocin drug products 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 
these oxytocin drug products were withdrawn from sale for reasons of 
safety or effectiveness.
    Accordingly, the Agency will continue to list these oxytocin drug 
products 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 
these oxytocin drug products may be approved by the Agency as long as 
they meet all other legal and regulatory requirements for the approval 
of ANDAs. FDA has determined that labeling for these oxytocin drug 
products should be revised to meet current standards and will advise 
ANDA applicants how to submit such labeling.

    Dated: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09299 Filed 4-21-15; 8:45 am]
BILLING CODE 4164-01-P