Determination That CHLOR-TRIMETON ALLERGY 12 HOUR (Chlorpheniramine Maleate) Extended Release Tablets, 8 Milligrams and 12 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 12625-12626 [2019-06382]

Download as PDF Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices SUPPLEMENTARY INFORMATION: amozie on DSK9F9SC42PROD with NOTICES I. Background An important part of CDER’s commitment to make safe and effective drugs available to all Americans is optimizing the efficiency and quality of the drug review process. To support this goal, CDER has initiated various training and development programs to promote high performance in its regulatory project management staff. CDER seeks to enhance review efficiency and review quality by providing the staff with a better understanding of the pharmaceutical industry and its operations. To this end, CDER is continuing its training program to give regulatory project managers the opportunity to tour pharmaceutical facilities. The goals are to provide the following: (1) Firsthand exposure to industry’s drug development processes and (2) a venue for sharing information about project management procedures (but not drug-specific information) with industry representatives. II. The Site Tours Program In this program, over a 2- to 3-day period, small groups (five or less) of CDER regulatory project managers, including a senior level regulatory project manager, can observe operations of pharmaceutical manufacturing and/or packaging facilities, pathology/ toxicology laboratories, and regulatory affairs operations. Neither this tour nor any part of the program is intended as a mechanism to inspect, assess, judge, or perform a regulatory function, but is meant rather to improve mutual understanding and to provide an avenue for open dialogue. During the Site Tours Program, regulatory project managers will also participate in daily workshops with their industry counterparts, focusing on selective regulatory issues important to both CDER staff and industry. The primary objective of the daily workshops is to learn about the team approach to drug development, including drug discovery, preclinical evaluation, tracking mechanisms, and regulatory submission operations. The overall benefit to regulatory project managers will be exposure to project management, team techniques, and processes employed by the pharmaceutical industry. By participating in this program, the regulatory project manager will grow professionally by gaining a better understanding of industry processes and procedures. III. Site Selection All travel expenses associated with the Site Tours Program will be the VerDate Sep<11>2014 18:45 Apr 01, 2019 Jkt 247001 responsibility of CDER; therefore, selection will be based on the availability of funds and resources for each fiscal year. Selection will also be based on firms having a favorable facility status as determined by FDA’s Office of Regulatory Affairs District Offices in the firms’ respective regions. Firms that want to learn more about this training opportunity or that are interested in offering a site tour should respond by sending a proposed agenda by email directly to Dan Brum (see DATES and FOR FURTHER INFORMATION CONTACT). Dated: March 27, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–06327 Filed 4–1–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–P–3691] Determination That CHLOR– TRIMETON ALLERGY 12 HOUR (Chlorpheniramine Maleate) Extended Release Tablets, 8 Milligrams and 12 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 or Agency) has determined that CHLOR–TRIMETON ALLERGY 12 HOUR (chlorpheniramine maleate) extended release tablets, 8 milligrams (mg) and 12 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 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: Katelyn Mineo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993–0002, 301– 796–1054. 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 SUMMARY: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 12625 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 (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. CHLOR–TRIMETON ALLERGY 12 HOUR (chlorpheniramine maleate) extended release tablets, 8 mg and 12 mg, are the subject of NDA 007638, held by Bayer HealthCare LLC (Bayer) and initially approved on August 15, 1950. CHLOR–TRIMETON ALLERGY 12 HOUR is indicated for temporary relief of the following symptoms due to hay fever or other upper respiratory allergies: sneezing; runny nose; itchy, watery eyes; itching of the nose or throat. In the 2005 NDA 007638 Annual Report received on October 14, 2005, Bayer notified FDA that CHLOR– TRIMETON ALLERGY 12 HOUR (chlorpheniramine maleate) extended release tablets, 8 mg, were being discontinued, and FDA moved the drug product to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. In a letter dated February 8, 2018, Bayer notified FDA that CHLOR– TRIMETON ALLERGY 12 HOUR (chlorpheniramine maleate) extended E:\FR\FM\02APN1.SGM 02APN1 amozie on DSK9F9SC42PROD with NOTICES 12626 Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices release tablets, 12 mg, were being discontinued, and FDA moved the drug product to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Avanthi, LLC, c/o KVK–TECH, INC., submitted a citizen petition dated September 27, 2018 (Docket No. FDA– 2018–P–3691), under 21 CFR 10.30, requesting that the Agency determine whether CHLOR–TRIMETON ALLERGY 12 HOUR (chlorpheniramine maleate) extended release tablets, 8 mg, were withdrawn from sale for reasons of safety or effectiveness. Although the citizen petition did not address the 12 mg strength, that strength has also been discontinued. On our own initiative, we have also determined whether that strength was 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 CHLOR–TRIMETON ALLERGY 12 HOUR (chlorpheniramine maleate) extended release tablets, 8 mg and 12 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that CHLOR– TRIMETON ALLERGY 12 HOUR (chlorpheniramine maleate), extended release tablets, 8 mg and 12 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of CHLOR–TRIMETON ALLERGY 12 HOUR (chlorpheniramine maleate), extended release tablets, 8 mg and 12 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 CHLOR–TRIMETON ALLERGY 12 HOUR (chlorpheniramine maleate), extended release tablets, 8 mg and 12 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 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 VerDate Sep<11>2014 18:45 Apr 01, 2019 Jkt 247001 for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: March 27, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–06382 Filed 4–1–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–0218] Pulmonary-Allergy Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The meeting of the Pulmonary-Allergy Drugs Advisory Committee scheduled for March 27, 2019, has been cancelled. This meeting was announced in the Federal Register of January 31, 2019. This meeting has been cancelled due to new information regarding the application. The Agency intends to continue evaluating the application and, as needed, will announce future meeting dates in the Federal Register. FOR FURTHER INFORMATION CONTACT: Cindy Chee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, Fax: 301–847–8533, email: PADAC@ fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting, which was announced in the Federal Register of January 31, 2019 (84 FR 748). SUMMARY: Dated: March 28, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–06389 Filed 4–1–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Pain Management Best Practices Inter-Agency Task Force Office of the Assistant Secretary for Health, Office of the AGENCY: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Secretary, Department of Health and Human Services. ACTION: Notice. As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Pain Management Best Practices Inter-Agency Task Force (Task Force). The meeting will be open to the public; public comment sessions will be held during the meeting. DATES: The Task Force meeting will be held on Thursday, May 9, 2019 from 10:00 a.m. to 5:30 p.m. and Friday, May 10, 2019, from 9:00 a.m. to 12:00 p.m. Eastern Time (ET). The agenda will be posted on the Task Force website at https://www.hhs.gov/ash/advisorycommittees/pain/. ADDRESSES: U.S. Department of Health and Human Services, Hubert H. Humphrey Building, Great Hall, 200 Independence Avenue SW, Washington, DC 20201. FOR FURTHER INFORMATION CONTACT: Alicia Richmond Scott, Designated Federal Officer, Pain Management Best Practices Inter-Agency Task Force, U.S. Department of Health and Human Services, Office of the Assistant Secretary for Health, 200 Independence Avenue SW, Room 736E, Washington, DC 20201. Phone: 240–453–2816. Email: paintaskforce@hhs.gov. SUPPLEMENTARY INFORMATION: Section 101 of the Comprehensive Addiction and Recovery Act of 2016 (CARA) requires the Secretary of Health and Human Services, in cooperation with the Secretaries of Defense and Veterans Affairs, to convene the Task Force no later than two years after the date of the enactment of CARA and develop a report to Congress with updates on best practices and recommendations on addressing gaps or inconsistencies for pain management, including chronic and acute pain. The Task Force is governed by the provisions of the Federal Advisory Committee Act (FACA), Public Law 92–463, as amended (5 U.S.C. App), which sets forth standards for the formation and use of advisory committees. In accordance with CARA, the Task Force will review clinical guidelines and identify gaps and/or inconsistencies for best practices for pain management, including chronic and acute pain, developed or adopted by federal agencies; propose updates to best practices and recommendations for identified gaps or inconsistencies; provide a 90 day the public comment period on any proposed updates and SUMMARY: E:\FR\FM\02APN1.SGM 02APN1

Agencies

[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12625-12626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06382]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-P-3691]


Determination That CHLOR-TRIMETON ALLERGY 12 HOUR 
(Chlorpheniramine Maleate) Extended Release Tablets, 8 Milligrams and 
12 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 or Agency) has 
determined that CHLOR-TRIMETON ALLERGY 12 HOUR (chlorpheniramine 
maleate) extended release tablets, 8 milligrams (mg) and 12 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 
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: Katelyn Mineo, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-1054.

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.
    CHLOR-TRIMETON ALLERGY 12 HOUR (chlorpheniramine maleate) extended 
release tablets, 8 mg and 12 mg, are the subject of NDA 007638, held by 
Bayer HealthCare LLC (Bayer) and initially approved on August 15, 1950. 
CHLOR-TRIMETON ALLERGY 12 HOUR is indicated for temporary relief of the 
following symptoms due to hay fever or other upper respiratory 
allergies: sneezing; runny nose; itchy, watery eyes; itching of the 
nose or throat.
    In the 2005 NDA 007638 Annual Report received on October 14, 2005, 
Bayer notified FDA that CHLOR-TRIMETON ALLERGY 12 HOUR 
(chlorpheniramine maleate) extended release tablets, 8 mg, were being 
discontinued, and FDA moved the drug product to the ``Discontinued Drug 
Product List'' section of the Orange Book. In a letter dated February 
8, 2018, Bayer notified FDA that CHLOR-TRIMETON ALLERGY 12 HOUR 
(chlorpheniramine maleate) extended

[[Page 12626]]

release tablets, 12 mg, were being discontinued, and FDA moved the drug 
product to the ``Discontinued Drug Product List'' section of the Orange 
Book.
    Avanthi, LLC, c/o KVK-TECH, INC., submitted a citizen petition 
dated September 27, 2018 (Docket No. FDA-2018-P-3691), under 21 CFR 
10.30, requesting that the Agency determine whether CHLOR-TRIMETON 
ALLERGY 12 HOUR (chlorpheniramine maleate) extended release tablets, 8 
mg, were withdrawn from sale for reasons of safety or effectiveness. 
Although the citizen petition did not address the 12 mg strength, that 
strength has also been discontinued. On our own initiative, we have 
also determined whether that strength was 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 CHLOR-TRIMETON ALLERGY 12 HOUR 
(chlorpheniramine maleate) extended release tablets, 8 mg and 12 mg, 
were not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
CHLOR-TRIMETON ALLERGY 12 HOUR (chlorpheniramine maleate), extended 
release tablets, 8 mg and 12 mg, were withdrawn for reasons of safety 
or effectiveness.
    We have carefully reviewed our files for records concerning the 
withdrawal of CHLOR-TRIMETON ALLERGY 12 HOUR (chlorpheniramine 
maleate), extended release tablets, 8 mg and 12 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 CHLOR-TRIMETON 
ALLERGY 12 HOUR (chlorpheniramine maleate), extended release tablets, 8 
mg and 12 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 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: March 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06382 Filed 4-1-19; 8:45 am]
BILLING CODE 4164-01-P

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