81 FR 34347 - 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Milligram, 0.137 Milligram, 0.15 Milligram, 0.175 Milligram, 0.1 Milligram, 0.2 Milligram, and 0.3 Milligram, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 104 (May 31, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 104 (May 31, 2016)
| Page Range | 34347-34348 | |
| FR Document | 2016-12655 |
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)] [Notices] [Pages 34347-34348] From the Federal Register Online [www.thefederalregister.org] [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Milligram, 0.137 Milligram, 0.15 Milligram, 0.175 Milligram, 0.1 Milligram, 0.2 Milligram, and 0.3 Milligram, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, were not withdrawn from sale for reasons of safety or effectiveness.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
![Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices 34347
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS 1—Continued
Number of Average bur-
E6(R2) Good Clinical Practice; International Council for Number of Total annual
records per den per rec- Total hours
Harmonisation; Draft Guidance for Industry recordkeepers records
recordkeeper ordkeeping
Developing a Quality Management System.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1
Number of re- Average bur-
E6(R2) Good Clinical Practice; International Council for Number of re- Total annual
sponses per den per re- Total hours
Harmonisation; Draft Guidance for Industry spondents responses
respondent sponse
Section 5.0.7—Risk Reporting ............................................. 1,457 4.6 6,702 3 20,107
Describing the Quality Management Approach Imple-
mented in a Clinical Trial and Summarizing Important
Deviations From the Predefined Quality Tolerance Lim-
its in a Clinical Study Report.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1
Number of
E6(R2) Good Clinical Practice; International Council for Number of Average bur-
records per Total records Total hours
Harmonisation; Draft Guidance for Industry recordkeepers den per record
recordkeeper
Section 5.0—Quality Management (including 5.0.1 to
5.0.7) ................................................................................ 218 1 218 60 13,080
Developing a Quality Management System.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1
Number of re- Average bur-
E6(R2) Good Clinical Practice; International Council for Number of re- Total annual
sponses per den per re- Total hours
Harmonisation; Draft Guidance for Industry sponses responses
respondent sponse
Section 5.0.7—Risk Reporting ............................................. 218 3.69 804 3 2,413
Describing the Quality Management Approach Imple-
mented in a Clinical Trial and Summarizing Important
Deviations From the Predefined Quality Tolerance Lim-
its in a Clinical Study Report.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The collections of information Dated: May 24, 2016. DEPARTMENT OF HEALTH AND
included in the sections marked as Leslie Kux, HUMAN SERVICES
‘‘ADDENDUM’’ in the E6(R2) draft Associate Commissioner for Policy.
guidance also refers to previously Food and Drug Administration
[FR Doc. 2016–12651 Filed 5–27–16; 8:45 am]
approved collections of information BILLING CODE 4164–01–P [Docket No. FDA–2015–P–0403]
found in FDA regulations. These
collections of information are subject to Determination That LEVOTHROID
review by OMB under the PRA. The (Levothyroxine Sodium) Tablets, 0.025
collections of information found in 21 Milligram, 0.05 Milligram, 0.075
CFR part 11 have been approved under Milligram, 0.088 Milligram, 0.112
OMB control number 0910–0303; the Milligram, 0.125 Milligram, 0.137
collections of information found in 21 Milligram, 0.15 Milligram, 0.175
CFR part 312 have been approved under Milligram, 0.1 Milligram, 0.2 Milligram,
OMB control number 0910–0014; and and 0.3 Milligram, Were Not Withdrawn
collections of information found in 21 From Sale for Reasons of Safety or
Effectiveness
sradovich on DSK3TPTVN1PROD with NOTICES
CFR part 314 have been approved under
OMB control number 0910–0001. The AGENCY: Food and Drug Administration,
collections of information found in 21 HHS.
CFR part 601 have been approved under ACTION: Notice.
OMB control number 0910–0338.
SUMMARY: The Food and Drug
Administration (FDA or Agency) has
determined that LEVOTHROID
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![34348 Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
(levothyroxine sodium) tablets, 0.025 FDA may not approve an ANDA that suggesting that this drug product was
milligram (mg), 0.05 mg, 0.075 mg, does not refer to a listed drug. withdrawn for reasons of safety or
0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, LEVOTHROID (levothyroxine effectiveness. We have carefully
0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and sodium) tablets, 0.025 mg, 0.05 mg, reviewed our files for records
0.3 mg, were not withdrawn from sale 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, concerning the withdrawal of
for reasons of safety or effectiveness. 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 LEVOTHROID (levothyroxine sodium)
This determination will allow FDA to mg, and 0.3 mg, are the subject of NDA tablets, 0.025 mg, 0.05 mg, 0.075 mg,
approve abbreviated new drug 021116, held by Lloyd Inc., and initially 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg,
applications (ANDAs) for LEVOTHROID approved on October 24, 2002. 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
(levothyroxine sodium) tablets, 0.025 LEVOTHROID is used for the following 0.3 mg, from sale. We have also
mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 indications: independently evaluated relevant
mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 • Hypothyroidism—As replacement literature and data for possible
mg, 0.1 mg, 0.2 mg, and 0.3 mg, if all or supplemental therapy in congenital postmarketing adverse events. We have
other legal and regulatory requirements or acquired hypothyroidism of any found no information that would
are met. etiology, except transient indicate that this drug product was
FOR FURTHER INFORMATION CONTACT:
hypothyroidism during the recovery withdrawn from sale for reasons of
phase of subacute thyroiditis. Specific safety or effectiveness.
Reena Raman, Center for Drug
indications include: Primary (thyroidal), Accordingly, the Agency will
Evaluation and Research, Food and
secondary (pituitary), and tertiary continue to list LEVOTHROID
Drug Administration, 10903 New
(hypothalamic) hypothyroidism and (levothyroxine sodium) tablets, 0.025
Hampshire Ave., Bldg. 51, Rm. 6284,
subclinical hypothyroidism. Primary mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112
Silver Spring, MD 20993–0002, 301–
hypothyroidism may result from mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175
796–7577.
functional deficiency, primary atrophy, mg, 0.1 mg, 0.2 mg, and 0.3 mg, in the
SUPPLEMENTARY INFORMATION: In 1984, partial or total congenital absence of the
Congress enacted the Drug Price ‘‘Discontinued Drug Product List’’
thyroid gland, or from the effects of section of the Orange Book. The
Competition and Patent Term surgery, radiation, or drugs, with or
Restoration Act of 1984 (Pub. L. 98–417) ‘‘Discontinued Drug Product List’’
without the presence of goiter. delineates, among other items, drug
(the 1984 amendments), which • Pituitary Thyrotropine-Stimulating
authorized the approval of duplicate products that have been discontinued
Hormone Suppression—In the treatment
versions of drug products under an from marketing for reasons other than
or prevention of various types of
ANDA procedure. ANDA applicants safety or effectiveness. ANDAs that refer
euthyroid goiters, including thyroid
must, with certain exceptions, show that to this drug product may be approved
nodules, subacute or chronic
the drug for which they are seeking by the Agency as long as they meet all
lymphocytic thyroiditis (Hashimoto’s
approval contains the same active other legal and regulatory requirements
thyroiditis), multinodular goiter, and as
ingredient in the same strength and for the approval of ANDAs. If FDA
an adjunct to surgery and radioiodine
dosage form as the ‘‘listed drug,’’ which therapy in the management of determines that labeling for this drug
is a version of the drug that was thyrotropin-dependent well- product should be revised to meet
previously approved. ANDA applicants differentiated thyroid cancer. current standards, the Agency will
do not have to repeat the extensive LEVOTHROID (levothyroxine advise ANDA applicants to submit such
clinical testing otherwise necessary to sodium) tablets, 0.025 mg, 0.05 mg, labeling.
gain approval of a new drug application 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, Dated: May 24, 2016.
(NDA). 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 Leslie Kux,
The 1984 amendments include what mg, and 0.3 mg are currently listed in Associate Commissioner for Policy.
is now section 505(j)(7) of the Federal the ‘‘Discontinued Drug Product List’’ [FR Doc. 2016–12655 Filed 5–27–16; 8:45 am]
Food, Drug, and Cosmetic Act (21 U.S.C. section of the Orange Book. BILLING CODE 4164–01–P
355(j)(7)), which requires FDA to Lachman Consultant Services, Inc.,
publish a list of all approved drugs. submitted a citizen petition dated
FDA publishes this list as part of the February 4, 2015 (Docket No. FDA– DEPARTMENT OF HEALTH AND
‘‘Approved Drug Products With 2015–P–0403), under 21 CFR 10.30, HUMAN SERVICES
Therapeutic Equivalence Evaluations,’’ requesting that the Agency determine
which is known generally as the whether LEVOTHROID (levothyroxine Food and Drug Administration
‘‘Orange Book.’’ Under FDA regulations, sodium) tablets, 0.025 mg, 0.05 mg,
drugs are removed from the list if the [Docket No. FDA–2016–N–0001]
0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg,
Agency withdraws or suspends 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 Clinical Trial Design Considerations
approval of the drug’s NDA or ANDA mg, and 0.3 mg, were withdrawn from for Malaria Drug Development; Notice
for reasons of safety or effectiveness or sale for reasons of safety or of Public Workshop; Correction
if FDA determines that the listed drug effectiveness.
was withdrawn from sale for reasons of After considering the citizen petition AGENCY: Food and Drug Administration,
safety or effectiveness (21 CFR 314.162). and reviewing Agency records and HHS.
A person may petition the Agency to based on the information we have at this ACTION: Notice; correction.
determine, or the Agency may time, FDA has determined under
determine on its own initiative, whether § 314.161 that LEVOTHROID SUMMARY: The Food and Drug
sradovich on DSK3TPTVN1PROD with NOTICES
a listed drug was withdrawn from sale (levothyroxine sodium) tablets, 0.025 Administration (FDA) is correcting a
for reasons of safety or effectiveness. mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 notice that appeared in the Federal
This determination may be made at any mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 Register of Tuesday, May 10, 2016 (81
time after the drug has been withdrawn mg, 0.1 mg, 0.2 mg, and 0.3 mg, were FR 28876). The document announced a
from sale, but must be made prior to not withdrawn for reasons of safety or public workshop entitled ‘‘Clinical Trial
approving an ANDA that refers to the effectiveness. The petitioner has Design Considerations for Malaria Drug
listed drug (§ 314.161 (21 CFR 314.161)). identified no data or other information Development.’’ The document was
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Document Created: 2016-05-28 03:57:38
Document Modified: 2016-05-28 03:57:38
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 81 FR 34347 |
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