Notice2021-11575
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Acetate) Injection, Equal to 0.2 Milligrams Base/Milliliter and Equal to 1 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
June 2, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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(octreotide acetate) injection, equal to (EQ) 0.2 milligrams (mg) base/milliliter (mL) and 1 mg base/mL, was not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
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<title>Federal Register, Volume 86 Issue 104 (Wednesday, June 2, 2021)</title>
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[Federal Register Volume 86, Number 104 (Wednesday, June 2, 2021)]
[Notices]
[Pages 29585-29586]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or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withdrawn from sale for reasons of safety or effectiveness.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,
<a href="/cdn-cgi/l/email-protection#2c7f584d4f5502674d42496c4a484d0244445f024b435a"><span class="__cf_email__" data-cfemail="2f7c5b4e4c5601644e414a6f494b4e0147475c01484059">[email protected]</span></a>.
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
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