Determination That LUPRON (Leuprolide Acetate) Injection, 1 Milligram/0.2 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 25060-25061 [2019-11243]

Download as PDF 25060 Federal Register / Vol. 84, No. 104 / Thursday, May 30, 2019 / Notices described in individual information collection requests. These data will be compared to benchmarks from the relevant CAHPS source surveys when available. Collection of these data from people who have been identified through CMS administrative data and administrative flags as part of specific minority populations will also serve as a critical validation step of this method for identifying difficult-to-study populations, thus making it easier to study beneficiaries in these groups in the future. Form Number: CMS–10701 (OMB control number: 0938–NEW); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 10,000; Total Annual Responses: 10,000; Total Annual Hours: 3,333. (For policy questions regarding this collection contact Luis Perez at 410–786–8557.) Dated: May 23, 2019. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993–0002, 240– 402–4246. SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, May 10, 2019 (84 FR 20633), in FR Doc. 2019– 09692, the following correction is made: On page 20633, in the first column, in the headings of the document, ‘‘[Docket No. FDA–2019–D–1798]’’ is corrected to read ‘‘[Docket No. FDA–2018–D–1456].’’ Dated: May 24, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–11313 Filed 5–29–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–P–4851] Determination That LUPRON (Leuprolide Acetate) Injection, 1 Milligram/0.2 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness [FR Doc. 2019–11227 Filed 5–29–19; 8:45 am] BILLING CODE 4120–01–P AGENCY: Food and Drug Administration, HHS. ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2018–D–1456] Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Overthe-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability; Correction Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability’’ that appeared in the Federal Register of May 10, 2019. The document announced the availability of a guidance for industry. The document was published with the incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New jbell on DSK3GLQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:08 May 29, 2019 Jkt 247001 The Food and Drug Administration (FDA or Agency) has determined that LUPRON (leuprolide acetate) injection, 1 milligram (mg)/0.2 milliliter (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: Meadow Platt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993–0002, 301– 796–1830, Meadow.Platt@fda.hhs.gov. 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 SUMMARY: Food and Drug Administration AGENCY: Notice. PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 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 (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, is the subject of NDA 019010, held by Abbvie Endocrine, Inc., and initially approved on April 9, 1985. LUPRON is indicated for palliative treatment of advanced prostatic cancer. LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, is currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Hetero Labs Limited submitted a citizen petition dated December 20, 2018 (Docket No. FDA–2018–P–4851), under 21 CFR 10.30, requesting that the Agency determine whether LUPRON (leuprolide acetate) injection, 1 mg/0.2 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 § 314.161 that LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records E:\FR\FM\30MYN1.SGM 30MYN1 25061 Federal Register / Vol. 84, No. 104 / Thursday, May 30, 2019 / Notices concerning the withdrawal of LUPRON (leuprolide acetate) injection, 1 mg/0.2 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 LUPRON (leuprolide acetate) injection, 1 mg/0.2 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 23, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–11243 Filed 5–29–19; 8:45 am] BILLING CODE 4164–01–P Food and Drug Administration [Docket No. FDA–2007–D–0429] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 1, 2019. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0641. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUMMARY: Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: ACTION: OMB Control Number 0910–0641— Extension Section 502(x) of the Federal, Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352(x)), added by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109– 462), requires the label of a nonprescription drug product marketed without an approved application in the United States to include a domestic address or domestic telephone number through which a manufacturer, packer, and distributor may receive a report of a serious adverse event associated with the product. The guidance document entitled ‘‘Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers’’ explains how FDA interprets this requirement. The guidance discusses the meaning of ‘‘domestic address’’ for purposes of the labeling requirements of section 502(x) of the FD&C Act, FDA’s recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label under section 502(x) of the FD&C Act, and FDA’s intent regarding enforcing the labeling requirements of section 502(x) of the FD&C Act. In the Federal Register of February 11, 2019 (84 FR 3192), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. Description of Respondents: Respondents to this collection of information are manufacturers, packers, and distributors whose name (under section 502(b)(1) of the FD&C Act) appears on the label of a nonprescription drug product marketed in the United States without an approved application. As indicated in table 1 of this document, we estimate that 300 manufacturers will revise approximately 900 labels to add a full domestic address or a domestic telephone number, and should they choose to adopt the guidance’s recommendation, to add a statement identifying the purpose of the domestic address or telephone number. We believe that designing the label change should not take longer than 4 hours per label. Automated printing of the labels should only require a few seconds per label. We estimate the burden of this collection of information as follows: jbell on DSK3GLQ082PROD with NOTICES TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NEW OTC DRUG PRODUCTS 1 Activity Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours Including a domestic address or phone number and a statement of its purpose on OTC drug labeling (section 502(x) of the FD&C Act) .................................................. 300 3 900 4 3,600 1 There are no capital costs or maintenance and operating costs associated with this collection of information. VerDate Sep<11>2014 18:08 May 29, 2019 Jkt 247001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\30MYN1.SGM 30MYN1

Agencies

[Federal Register Volume 84, Number 104 (Thursday, May 30, 2019)]
[Notices]
[Pages 25060-25061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11243]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-P-4851]


Determination That LUPRON (Leuprolide Acetate) Injection, 1 
Milligram/0.2 Milliliter, Was 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 LUPRON (leuprolide acetate) injection, 1 milligram 
(mg)/0.2 milliliter (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: Meadow Platt, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 301-
796-1830, [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 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.
    LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, is the subject 
of NDA 019010, held by Abbvie Endocrine, Inc., and initially approved 
on April 9, 1985. LUPRON is indicated for palliative treatment of 
advanced prostatic cancer. LUPRON (leuprolide acetate) injection, 1 mg/
0.2 mL, is currently listed in the ``Discontinued Drug Product List'' 
section of the Orange Book.
    Hetero Labs Limited submitted a citizen petition dated December 20, 
2018 (Docket No. FDA-2018-P-4851), under 21 CFR 10.30, requesting that 
the Agency determine whether LUPRON (leuprolide acetate) injection, 1 
mg/0.2 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 LUPRON (leuprolide acetate) injection, 1 mg/
0.2 mL, was not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, was withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records

[[Page 25061]]

concerning the withdrawal of LUPRON (leuprolide acetate) injection, 1 
mg/0.2 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 LUPRON (leuprolide 
acetate) injection, 1 mg/0.2 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 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11243 Filed 5-29-19; 8:45 am]
 BILLING CODE 4164-01-P

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