Determination That GLUCOPHAGE (Metformin Hydrochloride) Oral Tablets, 500 Milligrams, 850 Milligrams, and 1 Gram, and GLUCOPHAGE XR (Metformin Hydrochloride) Oral Extended-Release Tablets, 500 Milligrams and 750 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 72366-72367 [2019-28270]

Download as PDF 72366 Federal Register / Vol. 84, No. 250 / Tuesday, December 31, 2019 / Notices • What types of regulatory trends or information should be analyzed to benefit the regulatory process? • What technologies or policies could assist with sharing of data or interoperability of regulatory management systems across the Federal government? • What are the challenges and opportunities for third party service providers to use regulatory information alone or in combination with other data to deliver commercial services or analysis? • What technologies or policies could assist with increasing public access to data for or through commercial applications? khammond on DSKJM1Z7X2PROD with NOTICES In-Person Attendance Interested parties are invited to attend the public meetings to be held at GSA Headquarters, located at 1800 F St. NW, Washington, DC 20006. While walk-ins will be allowed if there is seating capacity, the public is encouraged to pre-register prior to the scheduled date due to seating limitations. Pre-register for the January 30, 2020, meeting at https://regulationsmanagement. eventbrite.com. Pre-register for the March 25, 2020, meeting at https:// regulationsmanagement2.eventbrite. com. Check for additional information regarding meeting logistics on regulations.gov, Docket No. 2019–0002; Sequence No. 35 as dates approach. Questions may be directed to eRulemaking@gsa.gov. Registration check-in will begin at 1:00 p.m. (ET), and each meeting will start promptly at 2:00 p.m. (ET). Depending on levels of attendance for registered attendees, walk-in registration may or may not be available. Updates on whether registration has reached capacity will be posted on regulations.gov, Docket No. 2019–0002; Sequence No. 35. Walk-ins may be admitted if registered attendees do not show. Attendees must present government-issued photo identification. Virtual Attendance Interested parties may also attend virtually through GSA’s virtual meeting platform, hosted by Adobe Connect. Further details on the virtual meeting will be made available via GSA Interact at https://interact.gsa.gov/group/ commercial-platform-initiative. Meeting Accommodations The public meeting is physically accessible to people with disabilities. Sign language interpretation and auxiliary aids will be available at the meetings and online. Any specific requests for accommodations and VerDate Sep<11>2014 17:30 Dec 30, 2019 Jkt 250001 auxiliary aids must be directed to eRulemaking@gsa.gov no later than 10 working days prior to the scheduled meetings. Panel Presentations GSA intends to conduct two townhall/panel style discussions, with each event focused on the respective topics outlined above. Each meeting is expected to consist of two panels with three to five participants per panel. Each panel is expected to run 50 minutes, with 45 minutes of panel discussion and 10 minutes of audience questions. Subject matter experts interested in serving on a panel at one or both public meetings must submit their proposals, to include a resume, an indication of the selected meeting or meetings, and a synopsis of their proposed topics and key points of no more than 250 words, no later than the following dates: For the January 30, 2020, meeting, proposals are due midnight January 10, 2020. For the March 25, 2020, meeting, proposals are due midnight March 2, 2020. Submissions are to be emailed to eRulemaking@gsa.gov. GSA will select the panelists and will formally notify and coordinate with them in advance of the respective meeting. In selecting panelists, GSA will seek an array of perspectives, backgrounds, and experiences. Dated: December 24, 2019. Tobias Q. Schroeder, Director, eRulemaking Program Management Office, Office of Regulation Management, Office of Government-wide Policy, General Services Administration. [FR Doc. 2019–28242 Filed 12–30–19; 8:45 am] BILLING CODE 6820–EP–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–P–3877] Determination That GLUCOPHAGE (Metformin Hydrochloride) Oral Tablets, 500 Milligrams, 850 Milligrams, and 1 Gram, and GLUCOPHAGE XR (Metformin Hydrochloride) Oral Extended-Release Tablets, 500 Milligrams and 750 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) SUMMARY: PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 has determined that, GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 milligrams (mg), 850 mg, and 1 gram (g), and GLUCOPHAGE XR (metformin hydrochloride) oral extended-release tablets, 500 mg and 750 mg, were 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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Carlarease Hunter, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993–0002, 301– 796–3702, Carlarease.Hunter@ 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 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 E:\FR\FM\31DEN1.SGM 31DEN1 72367 Federal Register / Vol. 84, No. 250 / Tuesday, December 31, 2019 / Notices 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. GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 mg, 850 mg, and 1 g, are the subject of NDA 020357, held by EMD Serono Inc. and initially approved on March 3, 1995. GLUCOPHAGE is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 mg, 850 mg, and 1 g, are currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. GLUCOPHAGE XR (metformin hydrochloride) oral extended-release tablets, 500 mg and 750 mg, are the subject of NDA 021202, held by EMD Serono Inc. and initially approved on October 13, 2000. GLUCOPHAGE XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. GLUCOPHAGE XR (metformin hydrochloride) oral extended-release tablets, 500 mg and 750 mg, are currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Harman Finochem Ltd. submitted a citizen petition dated August 17, 2019 (Docket No. FDA–2019–P–3877), under 21 CFR 10.30, requesting that FDA confirm that GLUCOPHAGE (metformin hydrochloride) oral tablets were not withdrawn from sale for reasons of safety or effectiveness. Although the citizen petition did not address the GLUCOPHAGE XR (metformin hydrochloride) oral extended-release tablets, 500 mg and 750 mg, those products have also been discontinued. On our own initiative, we have also determined whether those products were withdrawn for safety or effectiveness reasons. 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 GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 mg, 850 mg, and 1 g, and GLUCOPHAGE XR (metformin hydrochloride) oral extended-release tablets, 500 mg and 750 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that GLUCOPHAGE (metformin hydrochloride) oral tablets were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 mg, 850 mg, and 1 g, and GLUCOPHAGE XR (metformin hydrochloride) oral extended-release tablets, 500 mg and 750 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that these drug products were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 mg, 850 mg, and 1 g, and GLUCOPHAGE XR (metformin hydrochloride) oral extended-release tablets, 500 mg and 750 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. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to these drug products. Additional ANDAs for these drug products 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 these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: December 26, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–28270 Filed 12–30–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2013–N–0134; FDA– 2011–N–0902; FDA–2013–N–0662; FDA– 2013–N–0242; FDA–2019–N–1517; FDA– 2019–N–0549; FDA–2019–N–0305; FDA– 2012–N–0477; FDA–2016–D–2565, and FDA– 2018–N–4839] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. SUMMARY: The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at http://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. SUPPLEMENTARY INFORMATION: khammond on DSKJM1Z7X2PROD with NOTICES TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection Mammography Quality Standards Act Requirements ............................................................................................. Prescription Drug Product Labeling; Medication Guide Requirements ................................................................... Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed ...................................................................................................... Current Good Manufacturing Practice for Positron Emission ................................................................................. VerDate Sep<11>2014 17:30 Dec 30, 2019 Jkt 250001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\31DEN1.SGM 31DEN1 Date approval expires 0910–0309 0910–0393 10/31/2022 10/31/2022 0910–0513 0910–0667 10/31/2022 10/31/2022

Agencies

[Federal Register Volume 84, Number 250 (Tuesday, December 31, 2019)]
[Notices]
[Pages 72366-72367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28270]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-3877]


Determination That GLUCOPHAGE (Metformin Hydrochloride) Oral 
Tablets, 500 Milligrams, 850 Milligrams, and 1 Gram, and GLUCOPHAGE XR 
(Metformin Hydrochloride) Oral Extended-Release Tablets, 500 Milligrams 
and 750 Milligrams, 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, Agency, or we) has 
determined that, GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 
milligrams (mg), 850 mg, and 1 gram (g), and GLUCOPHAGE XR (metformin 
hydrochloride) oral extended-release tablets, 500 mg and 750 mg, were 
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 
these drug products, and it will allow FDA to continue to approve ANDAs 
that refer to these products as long as they meet relevant legal and 
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Carlarease Hunter, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-3702, [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

[[Page 72367]]

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.
    GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 mg, 850 mg, 
and 1 g, are the subject of NDA 020357, held by EMD Serono Inc. and 
initially approved on March 3, 1995. GLUCOPHAGE is indicated as an 
adjunct to diet and exercise to improve glycemic control in adults and 
pediatric patients 10 years of age and older with type 2 diabetes 
mellitus. GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 mg, 
850 mg, and 1 g, are currently listed in the ``Discontinued Drug 
Product List'' section of the Orange Book.
    GLUCOPHAGE XR (metformin hydrochloride) oral extended-release 
tablets, 500 mg and 750 mg, are the subject of NDA 021202, held by EMD 
Serono Inc. and initially approved on October 13, 2000. GLUCOPHAGE XR 
is indicated as an adjunct to diet and exercise to improve glycemic 
control in adults with type 2 diabetes mellitus. GLUCOPHAGE XR 
(metformin hydrochloride) oral extended-release tablets, 500 mg and 750 
mg, are currently listed in the ``Discontinued Drug Product List'' 
section of the Orange Book.
    Harman Finochem Ltd. submitted a citizen petition dated August 17, 
2019 (Docket No. FDA-2019-P-3877), under 21 CFR 10.30, requesting that 
FDA confirm that GLUCOPHAGE (metformin hydrochloride) oral tablets were 
not withdrawn from sale for reasons of safety or effectiveness. 
Although the citizen petition did not address the GLUCOPHAGE XR 
(metformin hydrochloride) oral extended-release tablets, 500 mg and 750 
mg, those products have also been discontinued. On our own initiative, 
we have also determined whether those products were withdrawn for 
safety or effectiveness reasons.
    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 GLUCOPHAGE (metformin hydrochloride) oral 
tablets, 500 mg, 850 mg, and 1 g, and GLUCOPHAGE XR (metformin 
hydrochloride) oral extended-release tablets, 500 mg and 750 mg, were 
not withdrawn for reasons of safety or effectiveness. The petitioner 
has identified no data or other information suggesting that GLUCOPHAGE 
(metformin hydrochloride) oral tablets were withdrawn for reasons of 
safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of GLUCOPHAGE (metformin 
hydrochloride) oral tablets, 500 mg, 850 mg, and 1 g, and GLUCOPHAGE XR 
(metformin hydrochloride) oral extended-release tablets, 500 mg and 750 
mg, from sale. We have also independently evaluated relevant literature 
and data for possible postmarketing adverse events. We have reviewed 
the available evidence and determined that these drug products were not 
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list GLUCOPHAGE (metformin 
hydrochloride) oral tablets, 500 mg, 850 mg, and 1 g, and GLUCOPHAGE XR 
(metformin hydrochloride) oral extended-release tablets, 500 mg and 750 
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. FDA will not begin 
procedures to withdraw approval of approved ANDAs that refer to these 
drug products. Additional ANDAs for these drug products 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 these drug products should be revised to meet current 
standards, the Agency will advise ANDA applicants to submit such 
labeling.

    Dated: December 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28270 Filed 12-30-19; 8:45 am]
 BILLING CODE 4164-01-P