Document ID: FDA-2020-N-1816-0001
Agency: fda
Document Type: Notice
Title: Lavipharm Laboratories, Inc., et al.; Proposal To Withdraw Approval of Five Abbreviated New Drug Applications; Opportunity for a Hearing
Posted Date: 2020-09-25T04:00Z

[Federal Register Volume 85, Number 187 (Friday, September 25, 2020)]
[Notices]
[Pages 60474-60476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21186]

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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.; Proposal To Withdraw 
Approval of Five Abbreviated New Drug Applications; Opportunity for a 
Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Drug Evaluation and Research (CDER) is proposing to withdraw approval 
of five abbreviated new drug applications (ANDAs) and is announcing an 
opportunity for the ANDA holders to request a hearing on this proposal. 
The basis for the proposal is that the 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: The ANDA holders may submit a request for a hearing by October 
26, 2020. Submit all data, information, and analyses upon which the 
request for a hearing relies November 24, 2020. Submit electronic or 
written comments by November 24, 2020.

ADDRESSES: The request for a hearing may be submitted by the ANDA 
holders by either of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments to submit your request 
for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a 
hearing, will be posted to the docket unchanged.

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.
     Because your request for a hearing will be made public, 
you are solely responsible for ensuring that your request 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. The request for a hearing must include the 
Docket No. FDA-2020-N-1816 ``Lavipharm Laboratories, Inc., et al.; 
Proposal To Withdraw Approval of Five Abbreviated New Drug 
Applications; Opportunity for a Hearing.'' The request for a hearing 
will be placed in the docket and publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
    The ANDA holders may submit all data and analyses upon which the 
request for a hearing relies in the same manner as the request for a 
hearing except as follows:
     Confidential Submissions--To submit any data analyses with 
confidential information that you do not wish to be made publicly 
available, submit your data and analyses only as a written/paper 
submission. You should submit two copies total of all data and 
analyses. 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 
any decisions on this matter. 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 
or available at the Dockets Management Staff between 9 a.m. and 4 p.m., 
Monday through Friday, 240-402-7500. Submit both copies to the Dockets 
Management Staff. Any information marked as ``confidential'' will not 
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and 
other applicable disclosure law.
    Comments Submitted by Other Interested Parties: For all comments 
submitted by other interested parties, submit comments as follows:

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.

[[Page 60475]]

     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-2020-N-1816 for ``Lavipharm Laboratories, Inc., et al.; Proposal To 
Withdraw Approval of Five Abbreviated New Drug Applications; 
Opportunity for a Hearing.'' Received comments, those filed in a timely 
manner (see ADDRESSES), 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, 240-402-7500.
     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 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 Sec.  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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.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, 240-402-7500.

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.

SUPPLEMENTARY INFORMATION: The holder of an approved ANDA to market a 
new drug for human use is required to submit annual reports to FDA 
concerning its approved ANDA under Sec. Sec.  314.81 and 314.98 (21 CFR 
314.81 and 314.98). The holders of the approved ANDAs listed in table 1 
have repeatedly failed to submit the required annual reports and have 
not responded to the Agency's request for submission of the reports.
    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. We notified the holders of approved 
ANDAs in table 1 of the REMS requirement on September 28, 2017. The 
holders of the approved ANDAs listed in table 1 have failed to receive 
approval of a REMS for their products.

    Table 1--Approved 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.
------------------------------------------------------------------------

    Therefore, notice is given to the holders of the approved ANDAs 
listed in table 1 and to all other interested persons that the Director 
of CDER proposes to issue an order, under section 505(e)(2) of the FD&C 
Act (21 U.S.C. 355(e)(2)), withdrawing approval of the ANDAs and all 
amendments and supplements thereto on the grounds that the ANDA holders 
have failed to submit reports required under Sec. Sec.  314.81 and 
314.98 and section 505(k) of the FD&C Act, and have failed to receive 
approval of a REMS for their products in accordance with section 505-1 
of the FD&C Act.
    In accordance with section 505(e) of the FD&C Act and 21 CFR 
314.150(a) and (b)(1) and 21 CFR 314.200, the ANDA holders are hereby 
provided an opportunity for a hearing to show why the approval of the 
ANDAs identified above should not be withdrawn and an opportunity to 
raise, for administrative determination, all issues relating to the 
legal status of the drug products covered by these ANDAs.

[[Page 60476]]

    An ANDA holder who decides to seek a hearing must file the 
following: (1) a written notice of participation and request for a 
hearing (see DATES and ADDRESSES) and (2) the data, information, and 
analyses relied on to demonstrate that there is a genuine and 
substantial issue of fact that requires a hearing (see DATES and 
ADDRESSES). Any other interested person may also submit comments on 
this notice. The procedures and requirements governing this notice of 
opportunity for a hearing, notice of participation and request for a 
hearing, the information and analyses to justify a hearing, other 
comments, and a grant or denial of a hearing are contained in Sec.  
314.200 (21 CFR 314.200) and in 21 CFR part 12.
    The failure of an ANDA holder to file a timely written notice of 
participation and request for a hearing, as required by Sec.  314.200, 
constitutes an election by that ANDA holder not to avail itself of the 
opportunity for a hearing concerning CDER's proposal to withdraw 
approval of the ANDAs and constitutes a waiver of any contentions 
concerning the legal status of the drug products. FDA will then 
withdraw approval of the ANDAs, and the drug products may not 
thereafter be lawfully marketed or delivered for introduction into 
interstate commerce. Any new drug product introduced or delivered for 
introduction into interstate commerce without an approved ANDA is 
subject to regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or 
denials but must present specific facts showing that there is a genuine 
and substantial issue of fact that requires a hearing (Sec.  
314.200(g)). If a request for a hearing is not complete or is not 
supported, the Commissioner of Food and Drugs will enter summary 
judgment against the person who requests the hearing, making findings 
and conclusions, and denying a hearing (Sec.  314.200(g)(1)).
    All submissions under this notice of opportunity for a hearing must 
be filed in two copies. Except for data and information prohibited from 
public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the 
submissions may be seen at the Dockets Management Staff (see ADDRESSES) 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at https://www.regulations.gov.
    This notice is issued under section 505(e)(2) of the FD&C Act and 
under authority delegated to the Director of CDER by the Commissioner 
of Food and Drugs.

    Dated: September 16, 2020.
Patrizia Cavazzoni,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 2020-21186 Filed 9-24-20; 8:45 am]
BILLING CODE 4164-01-P