[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Notices]
[Pages 50041-50042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20662]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-2123]


Determination That ATROPINE SULFATE ANSYR PLASTIC SYRINGE 
(Atropine Sulfate Solution) Intravenous, Intramuscular, Subcutaneous, 
and Endotracheal, 0.5 Milligram/5 Milliliters (0.1 Milligram/
Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or 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, Agency, or we) has 
determined that ATROPINE SULFATE ANSYR PLASTIC SYRINGE (atropine 
sulfate solution) intravenous, intramuscular, subcutaneous, and 
endotracheal, 0.5 milligram (mg)/5 milliliters (mL) (0.1 mg/mL), was 
not withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for atropine sulfate solution intravenous, 
intramuscular, subcutaneous, and endotracheal, 0.5 mg/5 mL (0.1 mg/mL), 
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Carlarease Hunter, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-3702, [email protected].

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 
(Sec.  314.162 (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.

[[Page 50042]]

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.
    ATROPINE SULFATE ANSYR PLASTIC SYRINGE (atropine sulfate solution) 
intravenous, intramuscular, subcutaneous, and endotracheal, 0.5 mg/5 mL 
(0.1 mg/mL), is the subject of NDA 021146, held by Hospira, Inc., and 
initially approved on July 9, 2001. ATROPINE SULFATE ANSYR PLASTIC 
SYRINGE (atropine sulfate solution) intravenous, intramuscular, 
subcutaneous, and endotracheal, 0.5 mg/5 mL (0.1 mg/mL), is indicated 
for temporary blockade of severe or life-threatening muscarinic effects 
(e.g., as an antisialagogue, an antivagal agent, an antidote for 
organophosphorus or muscarinic mushroom poisoning, and to treat 
bradyasystolic cardiac arrest).
    ATROPINE SULFATE ANSYR PLASTIC SYRINGE (atropine sulfate solution) 
intravenous, intramuscular, subcutaneous, and endotracheal, 0.5 mg/5 mL 
(0.1 mg/mL), has never been marketed. In previous instances (see e.g., 
72 FR 9763 (March 5, 2007) and 61 FR 25497 (May 21, 1996)), the Agency 
has determined that, for purposes of Sec. Sec.  314.161 and 314.162, 
never marketing an approved drug product is equivalent to withdrawing 
the drug from sale.
    Lachman Consultants submitted a citizen petition dated May 1, 2019 
(Docket No. FDA-2019-P-2123), under 21 CFR 10.30, requesting that the 
Agency determine whether ATROPINE SULFATE ANSYR PLASTIC SYRINGE 
(atropine sulfate solution) intravenous, intramuscular, subcutaneous, 
and endotracheal, 0.5 mg/5 mL (0.1 mg/mL), 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 ATROPINE SULFATE ANSYR PLASTIC SYRINGE 
(atropine sulfate solution) intravenous, intramuscular, subcutaneous, 
and endotracheal, 0.5 mg/5 mL (0.1 mg/mL), was not withdrawn for 
reasons of safety or effectiveness. The petitioner has identified no 
data or other information suggesting that ATROPINE SULFATE ANSYR 
PLASTIC SYRINGE (atropine sulfate solution) intravenous, intramuscular, 
subcutaneous, and endotracheal, 0.5 mg/5 mL (0.1 mg/mL), was withdrawn 
for reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of ATROPINE SULFATE ANSYR 
PLASTIC SYRINGE (atropine sulfate solution) intravenous, intramuscular, 
subcutaneous, and endotracheal, 0.5 mg/5 mL (0.1 mg/mL), 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 drug product was withdrawn from sale for 
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list ATROPINE SULFATE 
ANSYR PLASTIC SYRINGE (atropine sulfate solution) intravenous, 
intramuscular, subcutaneous, and endotracheal, 0.5 mg/5 mL (0.1 mg/mL), 
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 ATROPINE 
SULFATE ANSYR PLASTIC SYRINGE (atropine sulfate solution) intravenous, 
intramuscular, subcutaneous, and endotracheal, 0.5 mg/5 mL (0.1 mg/mL), 
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: September 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20662 Filed 9-23-19; 8:45 am]
BILLING CODE 4164-01-P