[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]


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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Not Withdrawn From Sale for Reasons of Safety or Effectiveness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.

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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0.2 mg, and 0.3 mg, were not withdrawn from sale for reasons of safety 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