[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14451-14452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05324]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-P-1678]


Determination That NIPRIDE RTU (Sodium Nitroprusside), 10 
Milligrams/50 Milliliters (0.2 Milligrams/Milliliters), 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 or Agency) has 
determined that NIPRIDE RTU (sodium nitroprusside), 10 milligrams (mg)/
50 milliliters (mL) (0.2 mg/mL), was not withdrawn from sale for 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 sodium 
nitroprusside, 10 mg/50 mL (0.2 mg/mL), if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Michael Bernstein, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6240, Silver Spring, MD 20993-0002, 301-
796-3478, michael.bernstein@fda.hhs.gov.

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.
    NIPRIDE RTU (sodium nitroprusside), 10 mg/50 mL (0.2 mg/mL), is the 
subject of NDA 209387, held by Exela Pharma Sciences, LLC, and 
initially approved on March 8, 2017. NIPRIDE RTU is indicated for 
immediate reduction of blood pressure of adult and pediatric patients 
in hypertensive crises; induction and maintenance of controlled 
hypotension in adults and children during surgery, to reduce bleeding; 
and treatment of acute heart failure to reduce left ventricular end-
diastolic pressure, pulmonary capillary wedge pressure, peripheral 
vascular resistance, and mean arterial blood pressure.
    NIPRIDE RTU (sodium nitroprusside), 10 mg/50 mL (0.2 mg/mL), is 
currently listed in the ``Discontinued Drug Product List'' section of 
the Orange Book.
    Cardinal Health Regulatory Sciences submitted a citizen petition 
dated July 15, 2020 (Docket No. FDA-2020-P-1678), under 21 CFR 10.30, 
requesting that the Agency determine whether NIPRIDE RTU (sodium 
nitroprusside), 10 mg/50 mL (0.2 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 NIPRIDE RTU (sodium nitroprusside), 10 mg/50 
mL (0.2 mg/mL), was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other

[[Page 14452]]

information suggesting that NIPRIDE RTU (sodium nitroprusside), 10 mg/
50 mL (0.2 mg/mL), was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of NIPRIDE RTU (sodium nitroprusside), 10 mg/
50 mL (0.2 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 NIPRIDE RTU (sodium 
nitroprusside), 10 mg/50 mL (0.2 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 NIPRIDE RTU (sodium nitroprusside), 
10 mg/50 mL (0.2 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: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05324 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P


