PolyMedica Industries Inc., et al.; Withdrawal of Approval of Three New Drug Applications

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Published

September 13, 2021

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

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.

Full Text

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<title>Federal Register, Volume 86 Issue 174 (Monday, September 13, 2021)</title>
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[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Pages 50886-50887]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-19689]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0104]


PolyMedica Industries Inc., 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DATES: Approval is withdrawn as of September 13, 2021.

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, <a href="/cdn-cgi/l/email-protection#2b604246494e59475205674e43594d4e474f6b4d4f4a05434358054c445d"><span class="__cf_email__" data-cfemail="7b301216191e09170255371e13091d1e171f3b1d1f1a55131308551c140d">[email&#160;protected]</span></a>.

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 March 3, 2021 (86 FR 12474), FDA 
published a notice offering an opportunity for a hearing (NOOH) on a 
proposal to withdraw approval of those 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.

     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 016401................  Neopap                 PolyMedica Industries
                             (acetaminophen)        Inc., 2 Constitution
                             Suppositories, 120     Way, Woburn, MA
                             milligrams (mg).       01801.
NDA 050266................  Achromycin             Storz Ophthalmics
                             (tetracycline          Inc. (subsidiary of
                             hydrochloride (HCl))   American Cyanamid
                             Ophthalmic Ointment,   Co.), 401 North
                             10 mg/gram.            Middletown Rd.,
                                                    Pearl River, NY
                                                    10965.
NDA 050268................  Achromycin             Do.
                             (tetracycline HCl)
                             Ophthalmic
                             Suspension, 1%.
------------------------------------------------------------------------

    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 is hereby 
withdrawn as of September 13, 2021.


[[Page 50887]]


    Dated: September 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19689 Filed 9-10-21; 8:45 am]
BILLING CODE 4164-01-P


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