[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.

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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DATES: Approval is withdrawn as of April 9, 2021.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
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       Application No.                Drug                Applicant
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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.
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[[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