Document ID: FDA-2020-N-0419-0001
Agency: fda
Document Type: Notice
Title: Pan American Laboratories, LLC, et al.; Withdrawal of Approval of Three New
Drug Applications
Posted Date: 2020-03-17T04:00Z

[Federal Register Volume 85, Number 52 (Tuesday, March 17, 2020)]
[Notices]
[Pages 15192-15193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05498]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0419]

Pan American Laboratories, LLC, et al.; Withdrawal of Approval of 
Three 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 three new drug applications (NDAs) from multiple holders of those 
NDAs. The basis for the withdrawal is that these NDA holders have 
repeatedly failed to file required annual reports for those NDAs.

DATES: Approval is withdrawn as of March 17, 2020.

FOR FURTHER INFORMATION CONTACT: Kimberly S. 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 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.  314.81 
(21 CFR 314.81).
    In the Federal Register of November 18, 2019 (84 FR 63661), FDA 
published a notice offering an opportunity for a hearing (NOOH) on a 
proposal to withdraw approval of these NDAs because the holders of 
those NDAs had repeatedly failed to submit the required annual reports 
for those NDAs. The holders of the NDAs identified in table 1 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 an election by those holders of the NDAs not to make use of 
the opportunity for a hearing concerning the proposal to withdraw 
approval of their NDAs and a waiver of any contentions concerning the 
legal status of the drug products. Therefore, FDA is withdrawing 
approval of the three applications listed in table 1 of this document. 
FDA notes that the NOOH also proposed to withdraw approval of NDA 
018663, but FDA has decided not to pursue withdrawal of approval of 
this NDA at this time.

[[Page 15193]]

     Table 1--Approved NDAs for Which Required Reports Have Not Been
                                Submitted
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    Application No.               Drug                  NDA holder
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NDA 014217............  Maolate (chlorphenesin   Pan American
                         carbamate) Tablet, 400   Laboratories, LLC,
                         milligrams (mg).         4099 Highway 190,
                                                  Covington, LA 70433.
NDA 020530............  Iontocaine (epinephrine  Iomed, Inc., 2441 South
                         and lidocaine            3850 West, Suite A,
                         hydrochloride (HCl))     Salt Lake City, UT
                         Topical Solution, 0.01   84120-9941.
                         mg/milliliter; 2%.
NDA 021504............  LidoSite Topical         Vyteris, Inc., 13-01
                         System: LidoSite Patch   Pollitt Dr., Fair
                         (lidocaine HCl and       Lawn, NJ 07410.
                         epinephrine topical
                         iontophoretic patch)
                         10%/0.1% and LidoSite
                         Controller.
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    FDA finds that the holders of the NDAs listed in table 1 have 
repeatedly failed to submit reports required by Sec.  314.81. In 
addition, under Sec.  314.200, FDA finds that the holders of the NDAs 
have waived any contentions concerning the legal status of the drug 
products. Therefore, under these findings, approval of the NDAs listed 
in table 1 and all amendments and supplements thereto are hereby 
withdrawn as of March 17, 2020.\1\
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    \1\ Although it was not a factor in FDA's determination, we note 
that all three drugs covered by these NDAs are in discontinued 
marketing status.

    Dated: March 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05498 Filed 3-16-20; 8:45 am]
 BILLING CODE 4164-01-P