[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31875-31876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14146]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-0692]


Determination That THAM Solution (Tromethamine) Injectable, 3.6 
Grams/100 Milliliters, Was Not Withdrawn From Sale for Reasons of 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 THAM Solution (tromethamine) injectable, 3.6 grams (g)/
100 milliliters (mL), was not withdrawn from sale for reasons of safety 
or effectiveness. This determination will allow FDA to approve 
abbreviated new

[[Page 31876]]

drug applications (ANDAs) for tromethamine injectable, 3.6g/100 mL, if 
all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Katelyn Mineo, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-1054.

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.
    THAM Solution (tromethamine) injectable, 3.6 g/100 mL, is the 
subject of NDA 013025, held by Hospira, Inc., and initially approved on 
December 16, 1965. THAM Solution is indicated for the prevention and 
correction of metabolic acidosis.
    In a letter dated February 26, 2018, Pfizer Inc., Hospira, Inc.'s 
parent company, notified FDA that THAM Solution (tromethamine) 
injectable, 3.6 g/100 mL, was being discontinued, and FDA moved the 
drug product to the ``Discontinued Drug Product List'' section of the 
Orange Book.
    Arent Fox LLP submitted a citizen petition dated January 30, 2019 
(Docket No. FDA-2019-P-0692), under 21 CFR 10.30, requesting that the 
Agency determine whether THAM Solution (tromethamine) injectable, 3.6 
g/100 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 THAM Solution (tromethamine) injectable, 3.6 
g/100 mL, was not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
THAM Solution (tromethamine) injectable, 3.6 g/100 mL, was withdrawn 
for reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of THAM Solution 
(tromethamine) injectable, 3.6 g/100 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 THAM Solution 
(tromethamine) injectable, 3.6 g/100 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 THAM Solution (tromethamine) 
injectable, 3.6 g/100 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: June 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14146 Filed 7-2-19; 8:45 am]
 BILLING CODE 4164-01-P