Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Reopening the Comment Period, 64929-64930 [2024-17645]

Download as PDF 64929 Federal Register / Vol. 89, No. 153 / Thursday, August 8, 2024 / Notices FDA has become aware that the drug products listed in the table are no longer being marketed. lotter on DSK11XQN23PROD with NOTICES1 TABLE 1—DRUG PRODUCTS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route NDA 009165 .......... DELATESTRYL .......... Testosterone Enanthate ....... Injectable; Injection ..... Endo Pharmaceuticals Inc. NDA 011145 .......... DIURIL ........................ Chlorothiazide Sodium ......... Injectable; Injection ..... Rising Pharma Holdings Inc. NDA 013217 .......... SKELAXIN .................. Metaxalone ........................... 200 Milligrams (mg)/Milliliter (mL). Equivalent to (EQ) 500 mg base/Vial. 800 mg ................................. Tablet; Oral ................. NDA 017710 .......... NALFON ..................... Fenoprofen Calcium ............. EQ 600 mg Base ................. Tablet; Oral ................. NDA 018716 .......... NDA 018827 .......... TRANDATE ................. LOTRISONE ............... 100 mg; 200 mg; 300 mg .... EQ 0.05% Base; 1% ............ Tablet; Oral ................. Cream; Topical ........... NDA 020080 .......... IMITREX ..................... Labetalol Hydrochloride ....... Betamethasone Dipropionate; Clotrimazole. Sumatriptan Succinate ......... NDA 020617 .......... NDA 020763 .......... PYTEST KIT ............... AMERGE .................... Urea, C–14 ........................... Naratriptan Hydrochloride .... Injectable; Subcutaneous. Capsule; Oral .............. Tablet; Oral ................. NDA 020897 .......... DITROPAN XL ............ Oxybutynin Chloride ............. EQ 6 mg Base/0.5 mL (EQ 12 mg Base/mL). 1 mCi .................................... EQ 1 mg Base; EQ 2.5 mg Base. 5 mg; 10 mg ......................... King Pharmaceuticals Research and Development LLC, a subsidiary of Pfizer Inc. Dista Products Co., a division of Eli Lilly and Co. Alvogen Inc. Organon LLC, a subsidiary of Organon and Co. GlaxoSmithKline. NDA 020918 .......... GLUCAGEN ................ Glucagon Hydrochloride ....... EQ 1 mg Base/Vial .............. NDA 020928 .......... NDA 021615 .......... GLUCAGON ............... RAZADYNE ER .......... Glucagon .............................. Galantamine Hydrobromide NDA 021627 .......... NDA 021652 .......... NDA 021743 .......... NAMENDA .................. EPZICOM .................... TARCEVA ................... Memantine Hydrochloride .... Abacavir Sulfate; Lamivudine Erlotinib Hydrochloride ......... NDA 021892 .......... OSMOPREP ............... NDA 022013 .......... NDA 022204 .......... NDA 022525 .......... OLUX E ....................... GELNIQUE ................. NAMENDA XR ............ Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate. Clobetasol Propionate .......... Oxybutynin Chloride ............. Memantine Hydrochloride .... 1 mg/Vial .............................. EQ 8 mg Base; EQ 16 mg Base; EQ 24 mg Base. 2 mg/mL ............................... EQ 600 mg Base, 300 mg ... EQ 25 mg Base; EQ 100 mg Base; EQ 150 mg Base. 0.398 grams (g)m; 1.102 (g) NDA 050168 .......... CORTISPORIN ........... NDA 050218 .......... CORTISPORIN ........... NDA 050278 .......... NDA 050578 .......... 0.05% ................................... 10% (100 mg/Packet) .......... 7 mg ..................................... 400 units/g 1%, EQ 3.5 mg Base/g, 5,000 units/g. ACHROMYCIN V ........ FORTAZ ...................... Bacitracin Zinc; Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate. Hydrocortisone Acetate; Neomycin Sulfate; Polymyxin B Sulfate. Tetracycline Hydrochloride ... Ceftazidime .......................... NDA 050679 .......... MAXIPIME .................. Cefepime Hydrochloride ....... NDA 202543 .......... LEVETIRACETAM IN SODIUM CHLORIDE. Levetiracetam ....................... FDA has reviewed its records and, under § 314.161, has determined that the drug products listed were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the drug products listed are unaffected by the discontinued marketing of the VerDate Sep<11>2014 17:24 Aug 07, 2024 Jkt 262001 Injectable; Injection ..... Capsule, Extended Release; Oral. Solution; Oral .............. Tablet; Oral ................. Tablet; Oral ................. Janssen Pharmaceuticals Inc. Novo Nordisk Pharmaceuticals Inc. Eli Lilly and Co. Janssen Pharmaceuticals Inc. Allergan Sales LLC. ViiV Healthcare Co. OSI Pharmaceuticals LLC. Tablet; Oral ................. Salix Pharmaceuticals Inc. Aerosol, Foam; Topical Gel; Transdermal ........ Capsule, Extended Release; Oral. Ointment; Topical ........ Mylan Pharmaceuticals Inc. Abbvie Inc. Abbvie Inc. Monarch Pharmaceuticals LLC. Cream; Topical ........... Monarch Pharmaceuticals LLC. 250 mg; 500 mg ................... 500 mg/Vial; 1 g/Vial; 2 g/ Vial; 6 g/Vial. Capsule; Oral .............. Injectable; Injection ..... EQ 500 mg Base/Vial; EQ 1 g Base/Vial; EQ 2 g Base/ Vial. 250 mg/50 mL (5 mg/mL) .... Injectable; Injection ..... Avet Pharmaceuticals Inc. PAI Holdings LLC DBA Pharmaceutical Associates Inc. Hospira Inc. Injectable; Intravenous HQ Specialty Pharma Corp. Dated: August 5, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–17649 Filed 8–7–24; 8:45 am] BILLING CODE 4164–01–P Frm 00064 Avent Inc. GlaxoSmithKline. 0.5%, EQ 3.5 mg Base/g, 10,000 units/g. products subject to these applications. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. 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. PO 00000 Tablet, Extended Release; Oral. Injectable; Injection ..... Applicant Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–2422] Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Reopening the Comment Period AGENCY: Food and Drug Administration, HHS. Notice of availability; reopening the comment period. ACTION: E:\FR\FM\08AUN1.SGM 08AUN1 64930 Federal Register / Vol. 89, No. 153 / Thursday, August 8, 2024 / Notices The Food and Drug Administration (FDA, the Agency, or we) is reopening the comment period for the proposed administrative order (proposed order) entitled ‘‘Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Overthe-Counter Human Use’’, announced in the Federal Register of June 14, 2024. We are taking this action due to technical difficulties with the OTC Monographs@FDA portal. Because comments cannot be submitted to the OTC Monographs@FDA portal at this time, submit comments on proposed order (OTC000035) to the Federal eRulemaking portal (Docket No. FDA– 2024–N–2422). DATES: FDA is reopening the comment period on proposed order (OTC000035) announced in the Federal Register of June 14, 2024 (89 FR 50593). Electronic comments or written comments must be submitted by September 27, 2024. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 27, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Other than using the Federal eRulemaking Portal to submit comments (instead of the OTC Monographs@FDA portal), follow the instructions for submitting comments on the proposed order (OTC000035) available in the OTCMonographs@FDA portal at https://dps.fda.gov/omuf. FOR FURTHER INFORMATION CONTACT: Helen Lee, Center for Drug Evaluation and Research (HFD–600), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–0138. SUPPLEMENTARY INFORMATION: In the Federal Register of June 14, 2024 (89 FR 50593), FDA announced the availability of proposed order (OTC000035) entitled ‘‘Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use.’’ The proposed administrative order (proposed order), if finalized, will amend the requirements for internal analgesic, antipyretic, and VerDate Sep<11>2014 17:24 Aug 07, 2024 Jkt 262001 antirheumatic drug products for overthe-counter (OTC) human use, as currently described in Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (OTC Monograph M013).1 Interested persons were originally given until July 29, 2024, to comment on the proposed order (OTC000035) via the OTC Monographs@FDA portal. However, as of June 14, 2024, technical difficulties prevented the electronic submission of comments through the OTC Monographs@FDA portal. Therefore, we are reopening the comment period for the proposed order (OTC000035) and are instead accepting comments through the Federal eRulemaking Portal. Accordingly, submit comments on the proposed order (OTC000035) electronically using Docket No. FDA–2024–N–2422 in the Federal eRulemaking Portal at https:// www.regulations.gov. The reopened comment period will close on September 27, 2024. The proposed order (OTC000035) remains available in the OTC Monographs@FDA portal at https:// dps.fda.gov/omuf. Other than using the Federal eRulemaking Portal to submit comments (instead of the OTC Monographs@FDA portal), follow the instructions for submitting comments on the proposed order (OTC000035) available in the OTC Monographs@FDA portal at https://dps.fda.gov/omuf. The proposed order contains general instructions for commenting, which otherwise remain applicable. Dated: August 5, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–17645 Filed 8–7–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–0008] Advisory Committee; Blood Products Advisory Committee; Renewal AGENCY: Food and Drug Administration, HHS. Notice; renewal of Federal advisory committee. ACTION: 1 OTC Monograph M013 is currently set forth in the Final Administrative Order OTC000027. We note that at 89 FR 50593 at 50594, the notice of availability for the proposed order to amend OTC Monograph M013 erroneously referred to ‘‘Final Administrative Order OTC000027’’ as ‘‘Final Administrative Order OTC000035.’’ PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA) is announcing the renewal of the Blood Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Blood Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 13, 2026, expiration date. DATES: Authority for the Blood Products Advisory Committee will expire on May 13, 2026, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Christina Vert, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993–0002, 240–731–3544, Christina.Vert@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102–3.65 and approval by the Department of Health and Human Services and by the General Services Administration, FDA is announcing the renewal of the Blood Products Advisory Committee (the Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility. The Committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood, products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which FDA has regulatory responsibility. The Committee also advises the Commissioner of Food and Drugs of its findings regarding screening and testing (to determine eligibility) of donors and labeling of the products, on clinical and laboratory studies involving such products, on the affirmation or revocation of biological products licenses, and on the quality and relevance of FDA’s research program, which provides the scientific support for regulating these agents. The Committee will function at times as a medical device panel under the Federal Food, Drug, and Cosmetic Act Medical Device Amendments of 1976. As such, the Committee recommends SUMMARY: E:\FR\FM\08AUN1.SGM 08AUN1

Agencies

[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64929-64930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17645]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2422]


Amending Over-the-Counter Monograph M013: Internal Analgesic, 
Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human 
Use; Reopening the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening the comment period.

-----------------------------------------------------------------------

[[Page 64930]]

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
reopening the comment period for the proposed administrative order 
(proposed order) entitled ``Amending Over-the-Counter Monograph M013: 
Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for 
Over-the-Counter Human Use'', announced in the Federal Register of June 
14, 2024. We are taking this action due to technical difficulties with 
the OTC Monographs@FDA portal. Because comments cannot be submitted to 
the OTC Monographs@FDA portal at this time, submit comments on proposed 
order (OTC000035) to the Federal eRulemaking portal (Docket No. FDA-
2024-N-2422).

DATES: FDA is reopening the comment period on proposed order 
(OTC000035) announced in the Federal Register of June 14, 2024 (89 FR 
50593). Electronic comments or written comments must be submitted by 
September 27, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 27, 2024. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Other than using the Federal eRulemaking Portal to submit comments 
(instead of the OTC Monographs@FDA portal), follow the instructions for 
submitting comments on the proposed order (OTC000035) available in the 
OTCMonographs@FDA portal at https://dps.fda.gov/omuf.

FOR FURTHER INFORMATION CONTACT: Helen Lee, Center for Drug Evaluation 
and Research (HFD-600), Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-0138.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 14, 2024 (89 
FR 50593), FDA announced the availability of proposed order (OTC000035) 
entitled ``Amending Over-the-Counter Monograph M013: Internal 
Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-
Counter Human Use.'' The proposed administrative order (proposed 
order), if finalized, will amend the requirements for internal 
analgesic, antipyretic, and antirheumatic drug products for over-the-
counter (OTC) human use, as currently described in Over-the-Counter 
Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug 
Products for Over-the-Counter Human Use (OTC Monograph M013).\1\
---------------------------------------------------------------------------

    \1\ OTC Monograph M013 is currently set forth in the Final 
Administrative Order OTC000027. We note that at 89 FR 50593 at 
50594, the notice of availability for the proposed order to amend 
OTC Monograph M013 erroneously referred to ``Final Administrative 
Order OTC000027'' as ``Final Administrative Order OTC000035.''
---------------------------------------------------------------------------

    Interested persons were originally given until July 29, 2024, to 
comment on the proposed order (OTC000035) via the OTC Monographs@FDA 
portal. However, as of June 14, 2024, technical difficulties prevented 
the electronic submission of comments through the OTC Monographs@FDA 
portal. Therefore, we are reopening the comment period for the proposed 
order (OTC000035) and are instead accepting comments through the 
Federal eRulemaking Portal. Accordingly, submit comments on the 
proposed order (OTC000035) electronically using Docket No. FDA-2024-N-
2422 in the Federal eRulemaking Portal at https://www.regulations.gov. 
The reopened comment period will close on September 27, 2024.
    The proposed order (OTC000035) remains available in the OTC 
Monographs@FDA portal at https://dps.fda.gov/omuf. Other than using the 
Federal eRulemaking Portal to submit comments (instead of the OTC 
Monographs@FDA portal), follow the instructions for submitting comments 
on the proposed order (OTC000035) available in the OTC Monographs@FDA 
portal at https://dps.fda.gov/omuf. The proposed order contains general 
instructions for commenting, which otherwise remain applicable.

    Dated: August 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17645 Filed 8-7-24; 8:45 am]
BILLING CODE 4164-01-P
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