Revocation of Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of and/or Diagnosis of Zika or Ebola Virus, 910-915 [2020-00063]

Download as PDF 910 Federal Register / Vol. 85, No. 5 / Wednesday, January 8, 2020 / Notices Application No. Drug Applicant ANDA 078665 ...................... Next Choice (levonorgestrel) Tablets, 0.75 mg .............. ANDA 086809 ...................... ANDA 087143 ...................... Spironolactone Tablets USP, 25 mg .............................. Acetasol HC (hydrocortisone and acetic acid) Otic Solution USP, 1% and 2%. ANDA 088432 ...................... Meperidine HCl Injection USP, 10 mg/mL ...................... ANDA 090288 ...................... Naratriptan Tablets USP, EQ 1 mg base and EQ 2.5 mg base. Gemcitabine for Injection USP, EQ 200 mg base/vial and EQ 1 g base/vial. Next Choice One Dose (levonorgestrel) Tablets, 1.5 mg Epinastine HCl Ophthalmic Solution, 0.05% .................. Foundation Consumer Healthcare, LLC, 1190 Omega Dr., Pittsburgh, PA 15205. CASI Pharmaceuticals, Inc., c/o Target Health, Inc. Actavis Mid Atlantic, LLC, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ICU Medical, Inc., 600 North Field Dr., Lake Forest, IL 60045. CASI Pharmaceuticals, Inc., c/o Target Health, Inc. ANDA 091597 ...................... ANDA 200670 ...................... ANDA 203384 ...................... Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of February 7, 2020. Approval of each entire application is withdrawn, including any strengths or products inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on February 7, 2020 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: January 2, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–5801] Revocation of Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of and/or Diagnosis of Zika or Ebola Virus AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the revocation of three Emergency Use Authorizations (EUAs) (the Authorizations) issued to OraSure Technologies, Inc. (OraSure) for the OraQuick Ebola Rapid Antigen Test used with whole blood specimens; jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:18 Jan 07, 2020 Jkt 250001 OraSure for the OraQuick Ebola Rapid Antigen Test used with cadaveric oral fluid swab specimens; and DiaSorin Inc. (DiaSorin) for the LIAISON XL Zika Capture IgM II assay. FDA revoked both of OraSure’s Authorizations on October 10, 2019, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in consideration of a De Novo classification request granted to OraSure for the OraQuick Ebola Rapid Antigen Test on October 10, 2019. FDA revoked DiaSorin’s Authorization on October 28, 2019, under the FD&C Act, in consideration of the premarket clearance of DiaSorin’s LIAISON XL Zika Capture IgM II assay, which FDA determined to be substantially equivalent to a legally marketed class II predicate device on October 28, 2019. The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document. OraSure’s Authorizations are revoked as of October 10, 2019. DiaSorin’s Authorization is revoked as of October 28, 2019. ADDRESSES: Submit written requests for single copies of the revocation(s) to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request or include a fax number to which the revocation may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocation. FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993–0002, 240–402–8155 (this is not a toll-free number). DATES: [FR Doc. 2020–00076 Filed 1–7–20; 8:45 am] Sagent Pharmaceuticals, Inc., 1901 North Roselle Rd., Schaumburg, IL 60195. Foundation Consumer Healthcare, LLC. CASI Pharmaceuticals, Inc., c/o Target Health, Inc. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the Project BioShield Act of 2004 (Pub. L. 108–276) and the Pandemic and AllHazards Preparedness Reauthorization Act of 2013 (Pub. L. 113–5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. First, on July 31, 2015, FDA issued an EUA to OraSure for the OraQuick Ebola Rapid Antigen Test used with whole blood specimens, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on September 14, 2015 (80 FR 55125), as required by section 564(h)(1) of the FD&C Act. In response to requests from OraSure, this EUA was amended on March 18, 2016, and January 30, 2019. Second, on March 4, 2016, FDA issued an EUA to OraSure for the OraQuick Ebola Rapid Antigen Test used with cadaveric oral fluid, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on April 22, 2016 (81 FR 23709), as required by section 564(h)(1) of the FD&C Act. In response to requests from OraSure, this EUA was amended on November 14, 2016, and February 1, 2019. Subsequently, on October 10, 2019, FDA granted a De Novo classification request for the OraQuick Ebola Rapid Antigen Test under the generic name ‘‘Device to detect antigens of biothreat microbial agents in human clinical specimens,’’ as Class II (special controls) under product code QID (https://www.accessdata.fda.gov/cdrh_ docs/pdf19/DEN190025.pdf). Third, on April 5, 2017, FDA issued an EUA to DiaSorin for the LIAISON XL E:\FR\FM\08JAN1.SGM 08JAN1 Federal Register / Vol. 85, No. 5 / Wednesday, January 8, 2020 / Notices Zika Capture IgM II assay, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on June 30, 2017 (82 FR 29886), and corrected on July 10, 2017 (82 FR 31783), as required by section 564(h)(1) of the FD&C Act. In response to requests from DiaSorin, this EUA was amended on November 6, 2017, and December 27, 2018. Subsequently, DiaSorin submitted a premarket notification to FDA for the LIAISON XL Zika Capture IgM II assay. On October 28, 2019, FDA determined that the LIAISON XL Zika Capture IgM II assay was substantially equivalent to a legally marketed class II predicate device under product code QFO with the generic name ‘‘Zika virus serological reagents’’ (https:// www.accessdata.fda.gov/cdrh_docs/ pdf19/K192046.pdf). II. EUA Criteria for Issuance No Longer Met jbell on DSKJLSW7X2PROD with NOTICES Under section 564(g)(2) of the FD&C Act, the Secretary of HHS may revoke an EUA if, among other things, the criteria for issuance are no longer met. Under section 564(c)(3) of the FD&C VerDate Sep<11>2014 17:18 Jan 07, 2020 Jkt 250001 Act, an EUA may be issued only if FDA concludes there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition. On October 10, 2019, FDA revoked the EUAs for OraSure’s OraQuick Ebola Rapid Antigen Test for use with whole blood specimens and cadaveric oral fluid, and on October 28, 2019, FDA revoked the EUA for DiaSorin’s LIAISON XL Zika Capture IgM II assay because the criteria for issuance were no longer met. FDA determined that the criteria for issuance of OraSure’s two Authorizations are no longer met because OraSure had a De Novo classification request granted for the OraQuick Ebola Rapid Antigen Test as a Class II device under the generic name ‘‘Device to detect antigens of biothreat microbial agents in human clinical specimens’’ on October 10, 2019. FDA also determined that the criteria for issuance of DiaSorin’s Authorization are no longer met because the LIAISON XL Zika Capture IgM II assay was determined to be substantially equivalent to a legally marketed class II predicate device with the generic name PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 911 ‘‘Zika virus serological reagents.’’ As such, in each case FDA concluded that there is an adequate, approved, and available alternative for purposes of section 564(c)(3) of the FD&C Act and accordingly revoked the Authorizations pursuant to section 564(g)(2)(B) of the Act. III. Electronic Access An electronic version of this document and the full text of the revocation are available on the internet at https://www.regulations.gov/. IV. The Revocations Having concluded that the criteria for revocations of the Authorizations under section 564(g) of the FD&C Act are met, FDA has revoked the EUAs for OraSure’s OraQuick Ebola Rapid Antigen Test for use with whole blood specimens and cadaveric oral fluid and for DiaSorin’s LIAISON XL Zika Capture IgM II assay. The revocations in their entirety follow and provide an explanation of the reasons for each revocation, as required by section 564(h)(1) of the FD&C Act. BILLING CODE 4164–22–P E:\FR\FM\08JAN1.SGM 08JAN1 VerDate Sep<11>2014 Federal Register / Vol. 85, No. 5 / Wednesday, January 8, 2020 / Notices 17:18 Jan 07, 2020 Jkt 250001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4725 E:\FR\FM\08JAN1.SGM 08JAN1 EN08JA20.011</GPH> jbell on DSKJLSW7X2PROD with NOTICES 912 VerDate Sep<11>2014 17:18 Jan 07, 2020 Jkt 250001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4725 E:\FR\FM\08JAN1.SGM 08JAN1 913 EN08JA20.012</GPH> jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 5 / Wednesday, January 8, 2020 / Notices VerDate Sep<11>2014 Federal Register / Vol. 85, No. 5 / Wednesday, January 8, 2020 / Notices 17:18 Jan 07, 2020 Jkt 250001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4725 E:\FR\FM\08JAN1.SGM 08JAN1 EN08JA20.013</GPH> jbell on DSKJLSW7X2PROD with NOTICES 914 Federal Register / Vol. 85, No. 5 / Wednesday, January 8, 2020 / Notices Notice. Food and Drug Administration The Food and Drug Administration (FDA or Agency) is withdrawing approval of 19 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. [Docket No. FDA–2019–N–5843] DATES: [FR Doc. 2020–00063 Filed 1–7–20; 8:45 am] BILLING CODE 4164–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: FOR FURTHER INFORMATION CONTACT: Food and Drug Administration, HHS. SUMMARY: Approval is withdrawn as of February 7, 2020. Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19 New Drug Applications jbell on DSKJLSW7X2PROD with NOTICES ACTION: 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. The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. SUPPLEMENTARY INFORMATION: Application No. Drug Applicant NDA 004570 ........................ NDA 009838 ........................ Heparin Sodium Injection, 1,000 units/milliliter (mL), 5,000 units/mL, and 10,000 units/mL. Reserpine Tablets, 0.1 milligram (mg) and 0.25 mg ...... NDA 017063 ........................ Ismotic (isosorbide solution), 100 grams (g)/220 mL ..... NDA 017521 ........................ Dextrose Injection, 0.2 g/mL, 0.3 g/mL, 0.4 g/mL, 0.5 g/ mL, 0.6 g/mL, and 0.7 g/mL. Imodium (loperamide hydrochloride (HCl)) Capsules, 2 mg. Pharmacia and Upjohn Co. (a subsidiary of Pfizer Inc.), 235 East 42nd St., New York, NY 10017–7555. Sandoz Inc., 2555 W. Midway Blvd., Broomfield, CO 80020–1632. Alcon Research, LLC, 6201 South Freeway, Fort Worth, TX 76134–2099. Baxter Healthcare Corp., 1 Baxter Parkway, Deerfield, IL 60015. Johnson and Johnson Consumer Inc., McNeil Consumer Healthcare Division, 7050 Camp Hill Rd., Fort Washington, PA 19034. Do. NDA 017690 ........................ NDA 017694 ........................ VerDate Sep<11>2014 17:18 Jan 07, 2020 Imodium (loperaminde HCl) Capsules, 2 mg ................. Jkt 250001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM 08JAN1 EN08JA20.014</GPH> Dated: January 2, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. 915

Agencies

[Federal Register Volume 85, Number 5 (Wednesday, January 8, 2020)]
[Notices]
[Pages 910-915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00063]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5801]


Revocation of Authorizations of Emergency Use of In Vitro 
Diagnostic Devices for Detection of and/or Diagnosis of Zika or Ebola 
Virus

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of three Emergency Use Authorizations (EUAs) (the 
Authorizations) issued to OraSure Technologies, Inc. (OraSure) for the 
OraQuick Ebola Rapid Antigen Test used with whole blood specimens; 
OraSure for the OraQuick Ebola Rapid Antigen Test used with cadaveric 
oral fluid swab specimens; and DiaSorin Inc. (DiaSorin) for the LIAISON 
XL Zika Capture IgM II assay. FDA revoked both of OraSure's 
Authorizations on October 10, 2019, under the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act), in consideration of a De Novo 
classification request granted to OraSure for the OraQuick Ebola Rapid 
Antigen Test on October 10, 2019. FDA revoked DiaSorin's Authorization 
on October 28, 2019, under the FD&C Act, in consideration of the 
premarket clearance of DiaSorin's LIAISON XL Zika Capture IgM II assay, 
which FDA determined to be substantially equivalent to a legally 
marketed class II predicate device on October 28, 2019. The 
revocations, which include an explanation of the reasons for each 
revocation, are reprinted in this document.

DATES: OraSure's Authorizations are revoked as of October 10, 2019. 
DiaSorin's Authorization is revoked as of October 28, 2019.

ADDRESSES: Submit written requests for single copies of the 
revocation(s) to the Office of Counterterrorism and Emerging Threats, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 
4338, Silver Spring, MD 20993-0002. Send one self-addressed adhesive 
label to assist that office in processing your request or include a fax 
number to which the revocation may be sent. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the revocation.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002, 240-402-8155 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the 
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) 
allows FDA to strengthen the public health protections against 
biological, chemical, nuclear, and radiological agents. Among other 
things, section 564 of the FD&C Act allows FDA to authorize the use of 
an unapproved medical product or an unapproved use of an approved 
medical product in certain situations.
    First, on July 31, 2015, FDA issued an EUA to OraSure for the 
OraQuick Ebola Rapid Antigen Test used with whole blood specimens, 
subject to the terms of the Authorization. Notice of the issuance of 
the Authorization was published in the Federal Register on September 
14, 2015 (80 FR 55125), as required by section 564(h)(1) of the FD&C 
Act. In response to requests from OraSure, this EUA was amended on 
March 18, 2016, and January 30, 2019.
    Second, on March 4, 2016, FDA issued an EUA to OraSure for the 
OraQuick Ebola Rapid Antigen Test used with cadaveric oral fluid, 
subject to the terms of the Authorization. Notice of the issuance of 
the Authorization was published in the Federal Register on April 22, 
2016 (81 FR 23709), as required by section 564(h)(1) of the FD&C Act. 
In response to requests from OraSure, this EUA was amended on November 
14, 2016, and February 1, 2019. Subsequently, on October 10, 2019, FDA 
granted a De Novo classification request for the OraQuick Ebola Rapid 
Antigen Test under the generic name ``Device to detect antigens of 
biothreat microbial agents in human clinical specimens,'' as Class II 
(special controls) under product code QID (https://www.accessdata.fda.gov/cdrh_docs/pdf19/DEN190025.pdf).
    Third, on April 5, 2017, FDA issued an EUA to DiaSorin for the 
LIAISON XL

[[Page 911]]

Zika Capture IgM II assay, subject to the terms of the Authorization. 
Notice of the issuance of the Authorization was published in the 
Federal Register on June 30, 2017 (82 FR 29886), and corrected on July 
10, 2017 (82 FR 31783), as required by section 564(h)(1) of the FD&C 
Act. In response to requests from DiaSorin, this EUA was amended on 
November 6, 2017, and December 27, 2018. Subsequently, DiaSorin 
submitted a premarket notification to FDA for the LIAISON XL Zika 
Capture IgM II assay. On October 28, 2019, FDA determined that the 
LIAISON XL Zika Capture IgM II assay was substantially equivalent to a 
legally marketed class II predicate device under product code QFO with 
the generic name ``Zika virus serological reagents'' (https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192046.pdf).

II. EUA Criteria for Issuance No Longer Met

    Under section 564(g)(2) of the FD&C Act, the Secretary of HHS may 
revoke an EUA if, among other things, the criteria for issuance are no 
longer met. Under section 564(c)(3) of the FD&C Act, an EUA may be 
issued only if FDA concludes there is no adequate, approved, and 
available alternative to the product for diagnosing, preventing, or 
treating the disease or condition. On October 10, 2019, FDA revoked the 
EUAs for OraSure's OraQuick Ebola Rapid Antigen Test for use with whole 
blood specimens and cadaveric oral fluid, and on October 28, 2019, FDA 
revoked the EUA for DiaSorin's LIAISON XL Zika Capture IgM II assay 
because the criteria for issuance were no longer met. FDA determined 
that the criteria for issuance of OraSure's two Authorizations are no 
longer met because OraSure had a De Novo classification request granted 
for the OraQuick Ebola Rapid Antigen Test as a Class II device under 
the generic name ``Device to detect antigens of biothreat microbial 
agents in human clinical specimens'' on October 10, 2019.
    FDA also determined that the criteria for issuance of DiaSorin's 
Authorization are no longer met because the LIAISON XL Zika Capture IgM 
II assay was determined to be substantially equivalent to a legally 
marketed class II predicate device with the generic name ``Zika virus 
serological reagents.'' As such, in each case FDA concluded that there 
is an adequate, approved, and available alternative for purposes of 
section 564(c)(3) of the FD&C Act and accordingly revoked the 
Authorizations pursuant to section 564(g)(2)(B) of the Act.

III. Electronic Access

    An electronic version of this document and the full text of the 
revocation are available on the internet at https://www.regulations.gov/.

IV. The Revocations

    Having concluded that the criteria for revocations of the 
Authorizations under section 564(g) of the FD&C Act are met, FDA has 
revoked the EUAs for OraSure's OraQuick Ebola Rapid Antigen Test for 
use with whole blood specimens and cadaveric oral fluid and for 
DiaSorin's LIAISON XL Zika Capture IgM II assay. The revocations in 
their entirety follow and provide an explanation of the reasons for 
each revocation, as required by section 564(h)(1) of the FD&C Act.
BILLING CODE 4164-22-P

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    Dated: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00063 Filed 1-7-20; 8:45 am]
BILLING CODE 4164-01-C

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