[Federal Register Volume 85, Number 42 (Tuesday, March 3, 2020)]
[Notices]
[Page 12565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04319]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-3082]


Determination That NEO TECT KIT (Kit for the Preparation of 
Technetium TC-99m Depreotide Injection) Was Not Withdrawn From Sale for 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 NEO TECT KIT (Kit for the Preparation of Technetium Tc 
99m Depreotide Injection) was not withdrawn from sale for reasons of 
safety or effectiveness. This determination will allow FDA to approve 
abbreviated new drug applications (ANDAs) that refer to the product, if 
all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Michelle T. Weiner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240-
402-0374, [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 approved previously. 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 it 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.
    NEO TECT KIT (Kit for the Preparation of Technetium Tc 99m 
Depreotide Injection) is the subject of NDA 021012, currently held by 
CIS Bio International SA, approved on August 3, 1999. NEO TECT KIT is a 
scintigraphic imaging agent that identifies somatostatin receptor-
bearing pulmonary masses in patients presenting with pulmonary lesions 
on computed tomography and/or chest x ray who have known malignancy or 
who are highly suspect for malignancy.
    NEO TECT KIT (Kit for the Preparation of Technetium Tc 99m 
Depreotide Injection) is listed as Discontinued in the Orange Book.
    Andarix Pharmaceuticals, Inc. submitted a citizen petition dated 
June 25, 2019 (Docket No. FDA-2019-P-3082), under 21 CFR 10.30, 
requesting that the Agency determine whether NEO TECT KIT (Kit for the 
Preparation of Technetium Tc 99m Depreotide Injection) was withdrawn 
from sale voluntarily for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records 
with respect to NEO TECT KIT and based on the information we have at 
this time, FDA has determined under Sec.  314.161 that NEO TECT KIT 
(Kit for the Preparation of Technetium Tc 99m Depreotide Injection) was 
not withdrawn from sale for reasons of safety or effectiveness. FDA 
carefully reviewed its files for records concerning the withdrawal of 
NEO TECT KIT (Kit for the Preparation of Technetium Tc 99m Depreotide 
Injection) from sale. In addition, the Agency independently evaluated 
relevant literature and data for possible post-marketing 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 NEO TECT KIT (Kit for 
the Preparation of Technetium Tc 99m Depreotide Injection) 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 NEO TECT KIT (Kit for 
the Preparation of Technetium Tc 99m Depreotide Injection) 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: February 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04319 Filed 3-2-20; 8:45 am]
 BILLING CODE 4164-01-P