[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34347-34348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12655]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-P-0403]
Determination That LEVOTHROID (Levothyroxine Sodium) Tablets,
0.025 Milligram, 0.05 Milligram, 0.075 Milligram, 0.088 Milligram,
0.112 Milligram, 0.125 Milligram, 0.137 Milligram, 0.15 Milligram,
0.175 Milligram, 0.1 Milligram, 0.2 Milligram, and 0.3 Milligram, Were
Not Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that LEVOTHROID
[[Page 34348]]
(levothyroxine sodium) tablets, 0.025 milligram (mg), 0.05 mg, 0.075
mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg,
0.2 mg, and 0.3 mg, were not withdrawn from sale for reasons of safety
or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for LEVOTHROID (levothyroxine
sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125
mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, if all
other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Reena Raman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6284, Silver Spring, MD 20993-0002, 301-
796-7577.
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.
LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075
mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg,
0.2 mg, and 0.3 mg, are the subject of NDA 021116, held by Lloyd Inc.,
and initially approved on October 24, 2002. LEVOTHROID is used for the
following indications:
Hypothyroidism--As replacement or supplemental therapy in
congenital or acquired hypothyroidism of any etiology, except transient
hypothyroidism during the recovery phase of subacute thyroiditis.
Specific indications include: Primary (thyroidal), secondary
(pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical
hypothyroidism. Primary hypothyroidism may result from functional
deficiency, primary atrophy, partial or total congenital absence of the
thyroid gland, or from the effects of surgery, radiation, or drugs,
with or without the presence of goiter.
Pituitary Thyrotropine-Stimulating Hormone Suppression--In
the treatment or prevention of various types of euthyroid goiters,
including thyroid nodules, subacute or chronic lymphocytic thyroiditis
(Hashimoto's thyroiditis), multinodular goiter, and as an adjunct to
surgery and radioiodine therapy in the management of thyrotropin-
dependent well-differentiated thyroid cancer.
LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075
mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg,
0.2 mg, and 0.3 mg are currently listed in the ``Discontinued Drug
Product List'' section of the Orange Book.
Lachman Consultant Services, Inc., submitted a citizen petition
dated February 4, 2015 (Docket No. FDA-2015-P-0403), under 21 CFR
10.30, requesting that the Agency determine whether LEVOTHROID
(levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg,
0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
0.3 mg, were 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 LEVOTHROID (levothyroxine sodium) tablets,
0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg,
0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, were not withdrawn for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that this drug product was
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of LEVOTHROID
(levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg,
0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
0.3 mg, 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 LEVOTHROID
(levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg,
0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
0.3 mg, 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 this
drug product 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: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12655 Filed 5-27-16; 8:45 am]
BILLING CODE 4164-01-P