[Federal Register Volume 86, Number 104 (Wednesday, June 2, 2021)]
[Notices]
[Pages 29585-29586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11575]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-P-0163]


Determination That SANDOSTATIN (Octreotide Acetate) Injection, 
Equal to 0.2 Milligrams Base/Milliliter and Equal to 1 Milligrams Base/
Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or 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 SANDOSTATIN (octreotide acetate) injection, equal to 
(EQ) 0.2 milligrams (mg) base/milliliter (mL) and 1 mg base/mL, was not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination means that FDA will not begin procedures to withdraw 
approval of abbreviated new drug applications (ANDAs) that refer to 
this drug product, and it will allow FDA to continue to approve ANDAs 
that refer to the product as long as they meet relevant legal and 
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, 
[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

[[Page 29586]]

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.
    SANDOSTATIN (octreotide acetate) injection, EQ 0.2 mg base/mL and 
EQ 1 mg base/mL, is the subject of NDA 19667, held by Novartis 
Pharmaceuticals Corporation. NDA 19667 was initially approved on 
October 21, 1988, and the EQ 0.2 mg base/mL and EQ 1 mg base/mL 
strengths were approved on June 12, 1991. SANDOSTATIN is indicated to 
reduce blood levels of growth hormone and IGF-I (somatomedin C) in 
acromegaly patients who have had inadequate response to or cannot be 
treated with surgical resection, pituitary irradiation, and 
bromocriptine mesylate at maximally tolerated doses. SANDOSTATIN is 
also indicated for the symptomatic treatment of patients with 
metastatic carcinoid tumors where it suppresses or inhibits the severe 
diarrhea and flushing episodes associated with the disease. SANDOSTATIN 
is also indicated for the treatment of profuse watery diarrhea 
associated with vasoactive intestinal peptide-secreting tumors.
    In a letter received by the Agency on May 11, 2020, Novartis 
Pharmaceuticals Corporation notified FDA that SANDOSTATIN (octreotide 
acetate) injection, EQ 0.2 mg base/mL and EQ 1 mg base/mL, was being 
discontinued, and FDA moved the drug product to the ``Discontinued Drug 
Product List'' section of the Orange Book. Caplin Steriles Limited 
submitted a citizen petition dated February 5, 2021 (Docket No. FDA-
2021-P-0163), under 21 CFR 10.30, requesting that the Agency determine 
whether SANDOSTATIN (octreotide acetate) injection, EQ 0.2 mg base/mL 
and EQ 1 mg base/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 SANDOSTATIN (octreotide acetate) injection, EQ 
0.2 mg base/mL and EQ 1 mg base/mL, was not withdrawn for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that SANDOSTATIN (octreotide acetate) injection, 
EQ 0.2 mg base/mL and EQ 1 mg base/mL, was withdrawn for reasons of 
safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of SANDOSTATIN (octreotide acetate) 
injection, EQ 0.2 mg base/mL and EQ 1 mg base/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 SANDOSTATIN 
(octreotide acetate) injection, EQ 0.2 mg base/mL and EQ 1 mg base/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. FDA will not begin procedures to 
withdraw approval of approved ANDAs that refer to this drug product. 
Additional ANDAs for this drug product may also 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: May 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11575 Filed 6-1-21; 8:45 am]
BILLING CODE 4164-01-P