Lavipharm Laboratories, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications, 18542-18543 [2021-07335]

Download as PDF 18542 Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices I. Background CBER is announcing the availability of version 2.2 of the Specifications for Preparing and Submitting Postmarket ICSRs for Vaccines (available at https:// www.fda.gov/industry/about-esg/cbervaccine-icsr-implementation). The version update has been prepared to accommodate the submission of certain reports for combination products required by an FDA rule, ‘‘Postmarketing Safety Reporting for Combination Products’’, published in the Federal Register of December 20, 2016 (81 FR 92603) (available at https:// www.fda.gov/combination-products/ guidance-regulatory-information/ postmarketing-safety-reportingcombination-products). In addition, version 2.2 includes updated business rules (Appendix I of the Specifications) which provide details on data field specifications as well as updated sample Extensible Markup Language (XML) ICSR test files (available at https:// www.fda.gov/industry/about-esg/cbervaccine-icsr-implementation). The version update is not applicable to CBER-regulated drug products marketed for human use with approved NDAs and ANDAs; CBER-regulated therapeutic biological products marketed for human use with approved BLAs); Whole Blood or blood components; and HCT/Ps regulated solely under section 361 of the Public Health Service Act (42 U.S.C. 264). Vaccine manufacturers and others responsible for reporting ICSRs for vaccines can now transition to reporting in the updated version 2.2. Instructions to transition are available at https:// www.fda.gov/vaccines-blood-biologics/ getting-started-icsr-submission-fdaselectronic-vaccine-adverse-eventreporting-system-evaers. Manufacturers can contact the CBER ICSR Submissions Coordinator (CBERICSRSubmissions@ fda.hhs.gov) to inform of their intent to transition to version 2.2 of the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports for Vaccines. Although manufacturers are encouraged to transition to the updated version 2.2, CBER continues to accept reports in version 1.0 until further notice. Dated: April 5, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–07332 Filed 4–8–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1816] Lavipharm Laboratories, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing approval of five abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs. The basis for the withdrawal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs and have failed to satisfy the requirement to have an approved risk evaluation and mitigation strategy (REMS). SUMMARY: Approval is withdrawn as of April 9, 2021. FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and DATES: Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993–0002, 301– 796–3137, Kimberly.Lehrfeld@ fda.hhs.gov. The holder of an approved application to market a new drug for human use is required to submit annual reports to FDA concerning its approved application in accordance with §§ 314.81 and 314.98 (21 CFR 314.81 and 314.98). Additionally, in accordance with section 505–1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355–1), the Agency determined that a REMS is necessary for all the applicable listed drugs that the ANDAs in table 1 reference to ensure the benefits of the listed drugs outweigh the risks. In accordance with section 505–1(i) of the FD&C Act, an ANDA is required to have a REMS if the applicable listed drug has an approved REMS. In the Federal Register of September 25, 2020 (85 FR 60474), FDA published a notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw approval of these five ANDAs because the holders of these ANDAs had repeatedly failed to submit the required annual reports and have failed to receive approval of a REMS for their products. The holders of these ANDAs did not respond to the NOOH. Failure to file a written notice of participation and request for hearing as required by § 314.200 (21 CFR 314.200) constitutes a waiver of the opportunity for hearing by the holders of the ANDAs concerning the proposal to withdraw approval of their ANDAs and a waiver of any contentions concerning the legal status of the drug products. Therefore, FDA is withdrawing approval of the five applications listed in table 1 of this document. SUPPLEMENTARY INFORMATION: TABLE 1—ANDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED AND A REMS HAS NOT BEEN APPROVED Application No. Drug ANDA 077051 .. Fentanyl transdermal system film, extended-release, 25 micrograms (mcg)/hour (hr), 50 mcg/hr, 75 mcg/hr, and 100 mcg/hr. Acetaminophen and Codeine Phosphate Tablet, 325 milligrams (mg)/30 mg. Acetaminophen, Aspirin, and Codeine Phosphate Capsule, 150 mg/180 mg/60 mg. Acetaminophen, Aspirin, and Codeine Phosphate Capsule, 150 mg/180 mg/30 mg. Acetaminophen, Aspirin, and Codeine Phosphate Capsule, 150 mg/180 mg/15 mg. ANDA 085217 .. ANDA 085638 .. ANDA 085639 .. ANDA 085640 .. VerDate Sep<11>2014 17:45 Apr 08, 2021 Jkt 253001 PO 00000 Applicant Frm 00049 Fmt 4703 Sfmt 4703 Lavipharm Laboratories, Inc., 69 Princeton-Hightstown Rd., East Windsor, NJ 08520. Everylife, 2021 15th Avenue West, Seattle, WA 98119. Scherer Laboratories, Inc., 2301 Ohio Dr., Suite 234, Plano, TX 75093. Do. Do. E:\FR\FM\09APN1.SGM 09APN1 18543 Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices FDA finds that the holders of the ANDAs listed in table 1 have repeatedly failed to submit reports required by §§ 314.81 and 314.98 and section 505(k) of the FD&C Act (21 U.S.C. 355). Furthermore, the holders of the ANDAs listed in table 1 have failed to receive approval of a REMS for their products in accordance with section 505–1 of the FD&C Act. In addition, under § 314.200, FDA finds that the holders of the ANDAs have waived their opportunity for a hearing and any contentions concerning the legal status of the drug products. Therefore, based on these findings and pursuant to the authority under section 505(e) of the FD&C Act, approval of the ANDAs listed in table 1 and all amendments and supplements thereto is hereby withdrawn as of April 9, 2021. Dated: April 5, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–07335 Filed 4–8–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by May 10, 2021. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0249. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, 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. FDA Recall Regulations—21 CFR Part 7 [Docket No. FDA–2014–N–1031] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget SUMMARY: OMB Control Number 0910–0249— Extension This information collection helps support implementation of section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371) pertaining to product recalls, and regulations in part 7 (21 CFR part 7), subpart C promulgated to clarify and explain associated practices and procedures. Sections 7.49, 7.50, and 7.59 (21 CFR 7.49, 7.50, and 7.59) apply specifically to product recalls, which may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the Agency. Recalls are terminated when all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy. The regulations also provide for corrective actions to be taken regarding violative products and establish specific requirements that enable us to monitor and assess the adequacy of a firm’s efforts in this regard. The provisions include reporting to FDA on the initiation and termination of a recall, as well as submitting recall status reports and making required communication disclosures. Specific guidance regarding recalls is set forth in § 7.59, although product-specific guidance documents may also be developed to assist respondents to the information collection. Agency guidance documents are issued in accordance with our good guidance regulations in 21 CFR 10.115, which provide for public comment at any time. Consistent with § 7.50, all recalls monitored by FDA are included in an ‘‘Enforcement Report’’ once they are classified and may be listed prior to classification when FDA determines the firm’s removal or correction of a marketed product(s) meets the definition of a recall. Recall data in the Enforcement Report can be accessed through the weekly report publication, the quick and advanced search functionalities, and an Application Programming Interface (API). Instructions for navigating the report, accessing and using the API, and definitions of the report contents are found at https://www.fda.gov/safety/ enforcement-reports/enforcementreport-information-and-definitions. In the Federal Register of January 8, 2021 (86 FR 1508), we published a 60day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of the collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity; 21 CFR section Number of responses per respondent Total annual responses Average burden per response Total hours Firm initiated recall; § 7.46 ................................................... Termination of recall; § 7.55 ................................................ Recall status reports; § 7.53 ................................................ 2,779 2,095 2,779 1 1 13 2,779 2,095 36,127 25 10 10 69,475 20,950 361,270 Total .............................................................................. ........................ ........................ 41,001 ........................ 451,695 1 There are no capital costs or operating and maintenance costs associated with this collection of information. A review of Agency data shows that 8,337 recalls were conducted during fiscal years 2017 through 2019, for an VerDate Sep<11>2014 17:45 Apr 08, 2021 Jkt 253001 average of 2,779 recalls annually. We assume an average of 25 hours is needed to submit the requisite notification to PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 FDA, for a total annual burden of 69,475 hours. Similarly, during the same period, 6,287 recalls were terminated, E:\FR\FM\09APN1.SGM 09APN1

Agencies

[Federal Register Volume 86, Number 67 (Friday, April 9, 2021)]
[Notices]
[Pages 18542-18543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07335]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1816]


Lavipharm Laboratories, Inc., et al.; Withdrawal of Approval of 
Five Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of five abbreviated new drug applications (ANDAs) from multiple holders 
of those ANDAs. The basis for the withdrawal is that these ANDA holders 
have repeatedly failed to file required annual reports for those ANDAs 
and have failed to satisfy the requirement to have an approved risk 
evaluation and mitigation strategy (REMS).

DATES: Approval is withdrawn as of April 9, 2021.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].

SUPPLEMENTARY INFORMATION: The holder of an approved application to 
market a new drug for human use is required to submit annual reports to 
FDA concerning its approved application in accordance with Sec. Sec.  
314.81 and 314.98 (21 CFR 314.81 and 314.98). Additionally, in 
accordance with section 505-1 of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) (21 U.S.C. 355-1), the Agency determined that a REMS is 
necessary for all the applicable listed drugs that the ANDAs in table 1 
reference to ensure the benefits of the listed drugs outweigh the 
risks. In accordance with section 505-1(i) of the FD&C Act, an ANDA is 
required to have a REMS if the applicable listed drug has an approved 
REMS.
    In the Federal Register of September 25, 2020 (85 FR 60474), FDA 
published a notice offering an opportunity for a hearing (NOOH) on a 
proposal to withdraw approval of these five ANDAs because the holders 
of these ANDAs had repeatedly failed to submit the required annual 
reports and have failed to receive approval of a REMS for their 
products. The holders of these ANDAs did not respond to the NOOH. 
Failure to file a written notice of participation and request for 
hearing as required by Sec.  314.200 (21 CFR 314.200) constitutes a 
waiver of the opportunity for hearing by the holders of the ANDAs 
concerning the proposal to withdraw approval of their ANDAs and a 
waiver of any contentions concerning the legal status of the drug 
products. Therefore, FDA is withdrawing approval of the five 
applications listed in table 1 of this document.

 Table 1--ANDAs for Which Required Reports Have Not Been Submitted and a
                       REMS Has Not Been Approved
------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 077051.................  Fentanyl transdermal  Lavipharm
                               system film,          Laboratories, Inc.,
                               extended-release,     69 Princeton-
                               25 micrograms (mcg)/  Hightstown Rd.,
                               hour (hr), 50 mcg/    East Windsor, NJ
                               hr, 75 mcg/hr, and    08520.
                               100 mcg/hr.
ANDA 085217.................  Acetaminophen and     Everylife, 2021 15th
                               Codeine Phosphate     Avenue West,
                               Tablet, 325           Seattle, WA 98119.
                               milligrams (mg)/30
                               mg.
ANDA 085638.................  Acetaminophen,        Scherer
                               Aspirin, and          Laboratories, Inc.,
                               Codeine Phosphate     2301 Ohio Dr.,
                               Capsule, 150 mg/180   Suite 234, Plano,
                               mg/60 mg.             TX 75093.
ANDA 085639.................  Acetaminophen,         Do.
                               Aspirin, and
                               Codeine Phosphate
                               Capsule, 150 mg/180
                               mg/30 mg.
ANDA 085640.................  Acetaminophen,         Do.
                               Aspirin, and
                               Codeine Phosphate
                               Capsule, 150 mg/180
                               mg/15 mg.
------------------------------------------------------------------------


[[Page 18543]]

    FDA finds that the holders of the ANDAs listed in table 1 have 
repeatedly failed to submit reports required by Sec. Sec.  314.81 and 
314.98 and section 505(k) of the FD&C Act (21 U.S.C. 355). Furthermore, 
the holders of the ANDAs listed in table 1 have failed to receive 
approval of a REMS for their products in accordance with section 505-1 
of the FD&C Act. In addition, under Sec.  314.200, FDA finds that the 
holders of the ANDAs have waived their opportunity for a hearing and 
any contentions concerning the legal status of the drug products. 
Therefore, based on these findings and pursuant to the authority under 
section 505(e) of the FD&C Act, approval of the ANDAs listed in table 1 
and all amendments and supplements thereto is hereby withdrawn as of 
April 9, 2021.

    Dated: April 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07335 Filed 4-8-21; 8:45 am]
BILLING CODE 4164-01-P

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