[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Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or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not withdrawn from sale for reasons of safety or effectiveness.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