Determination That ESBRIET (Pirfenidone) Film Coated Tablets, 534 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 1469-1470 [2019-00847]

Download as PDF 1469 Federal Register / Vol. 84, No. 23 / Monday, February 4, 2019 / Notices ANNUAL BURDEN ESTIMATES Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours Prevention Services Data Collection ............................................................... 20 1 31 620 Estimated Total Annual Burden Hours: 620. In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chap 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington, DC 20201. Attn: ACF Reports Clearance Officer. Email address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2019–00895 Filed 2–1–19; 8:45 am] BILLING CODE 4184–25–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration amozie on DSK3GDR082PROD with NOTICES1 [Docket Nos. FDA–2018–P–1877 and FDA– 2018–P–3730] Determination That ESBRIET (Pirfenidone) Film Coated Tablets, 534 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 17:21 Feb 01, 2019 Jkt 247001 ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that ESBRIET (pirfenidone), film coated tablets, 534 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for pirfenidone, film coated tablets, 534 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Daniel Gottlieb, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993–0002, 301– 796–6650. 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 SUMMARY: PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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. ESBRIET (pirfenidone), film coated tablets, 534 mg, is the subject of NDA 208780, held by Genentech, Inc., and initially approved on January 11, 2017. ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis. ESBRIET (pirfenidone), film coated tablets, 534 mg, is currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Laurus Labs Ltd. submitted a citizen petition dated May 14, 2018 (Docket No. FDA–2018– P–1877), and Aziant Drug Research Solutions Pvt. Ltd. Submitted a citizen petition dated October 1, 2018 (FDA– 2018–P–3730), under 21 CFR 10.30, requesting that the Agency determine whether ESBRIET (pirfenidone), film coated tablets, 534 mg, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petitions and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that ESBRIET (pirfenidone), film coated tablets, 534 mg, was not withdrawn for reasons of safety or effectiveness. The petitioners have 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 ESBRIET (pirfenidone), film coated tablets, 534 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 ESBRIET (pirfenidone), film coated tablets, 534 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug E:\FR\FM\04FEN1.SGM 04FEN1 1470 Federal Register / Vol. 84, No. 23 / Monday, February 4, 2019 / Notices 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: January 17, 2019. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2019–00847 Filed 2–1–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0250] Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.’’ This guidance discusses FDA’s recommendations for developing the indication and usage statements in the prescribing information for drugs approved under the accelerated approval regulatory pathway (hereafter accelerated approval). The guidance also discusses labeling considerations for indications approved under accelerated approval when clinical benefit has been verified and FDA terminates the conditions of accelerated approval, or when FDA withdraws accelerated approval of an indication while other indications for the drug remain approved. This guidance finalizes the draft guidance of the same name issued March 25, 2014. DATES: The announcement of the guidance is published in the Federal Register on February 4, 2019. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:21 Feb 01, 2019 Jkt 247001 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2014–D–0250 for ‘‘Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway; Guidance for Industry; Availability.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002, or Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: John Gallagher, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6473, Silver Spring, MD 20993–0002, 240–402–4768; or E:\FR\FM\04FEN1.SGM 04FEN1

Agencies

[Federal Register Volume 84, Number 23 (Monday, February 4, 2019)]
[Notices]
[Pages 1469-1470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00847]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-P-1877 and FDA-2018-P-3730]


Determination That ESBRIET (Pirfenidone) Film Coated Tablets, 534 
Milligrams, 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 ESBRIET (pirfenidone), film coated tablets, 534 
milligrams (mg), was not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for pirfenidone, film coated tablets, 534 
mg, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Daniel Gottlieb, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 301-
796-6650.

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.
    ESBRIET (pirfenidone), film coated tablets, 534 mg, is the subject 
of NDA 208780, held by Genentech, Inc., and initially approved on 
January 11, 2017. ESBRIET is indicated for the treatment of idiopathic 
pulmonary fibrosis. ESBRIET (pirfenidone), film coated tablets, 534 mg, 
is currently listed in the ``Discontinued Drug Product List'' section 
of the Orange Book. Laurus Labs Ltd. submitted a citizen petition dated 
May 14, 2018 (Docket No. FDA-2018-P-1877), and Aziant Drug Research 
Solutions Pvt. Ltd. Submitted a citizen petition dated October 1, 2018 
(FDA-2018-P-3730), under 21 CFR 10.30, requesting that the Agency 
determine whether ESBRIET (pirfenidone), film coated tablets, 534 mg, 
was withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petitions and reviewing Agency 
records and based on the information we have at this time, FDA has 
determined under Sec.  314.161 that ESBRIET (pirfenidone), film coated 
tablets, 534 mg, was not withdrawn for reasons of safety or 
effectiveness. The petitioners have 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 ESBRIET (pirfenidone), film coated 
tablets, 534 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 ESBRIET 
(pirfenidone), film coated tablets, 534 mg, in the ``Discontinued Drug 
Product List'' section of the Orange Book. The ``Discontinued Drug 
Product List'' delineates, among other items, drug

[[Page 1470]]

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: January 17, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00847 Filed 2-1-19; 8:45 am]
 BILLING CODE 4164-01-P

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