Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications, 909-910 [2020-00076]

Download as PDF Federal Register / Vol. 85, No. 5 / Wednesday, January 8, 2020 / Notices 909 TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Type of respondent Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours State Animal Feed Regulatory Program in the United States ............................................................................... 34 1 34 569 19,346 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Respondents to the information collection are State agencies seeking to avail themselves of the options described in the document. State agencies that conduct feed inspections under contract are interested in implementing the standards. The total estimated annual recordkeeping burden for implementation is 569 hours per respondent. The burden was determined by capturing the average amount of time for each respondent to assess the current state of the program and work toward implementation of each of the 11 standards contained in the AFRPS. The hours per State feed regulatory program will average the same to account for continual improvement and selfsufficiency in the program. Our burden estimate reflects a decrease of 100,654 hours as a result of fewer respondents to the collection and a reevaluation of the time we ascribe for recordkeeping activities. [FR Doc. 2020–00073 Filed 1–7–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–5550] Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the SUMMARY: drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of February 7, 2020. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993–0002, 240– 402–6980, Martha.Nguyen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: 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 described 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. Application No. Drug Applicant ANDA 040448 ...................... Elite Laboratories, Inc., 165 Ludlow Ave., Northvale, NJ 07647. Arbor Pharmaceuticals, LLC, 6 Concourse Parkway, Suite 1800, Atlanta, GA 30328. Do. ANDA 073416 ...................... Phentermine Hydrochloride (HCl) Capsules USP, 30 milligrams (mg). E-Mycin (erythromycin) Delayed-Release Tablets USP, 250 mg and 333 mg. E.E.S. 200 (erythromycin ethylsuccinate) for Oral Suspension, Equivalent to (EQ) 200 mg base/5 milliliters (mL).E.E.S. 400 (erythromycin ethylsuccinate) for Oral Suspension, EQ 400 mg base/5 mL. EryDerm (erythromycin) Topical Solution USP, 2% ....... Pediamycin (erythromycin ethylsuccinate) Oral Suspension USP, EQ 200 mg base/5 mL Pediamycin 400 (erythromycin ethylsuccinate) Oral Suspension USP, EQ 400 mg base/5 mL. Claforan ADD-Vantage (cefotaxime) for Injection USP, EQ 1 gram (g) base/vial and EQ 2 g base/vial. Hydro-Ride (amiloride HCl and hydrochlorothiazide) Tablets, EQ 5 mg Anhydrous/50 mg. Clonidine HCl and Chlorthalidone Tablets USP, 0.3 mg/ 15 mg. Clonidine HCl and Chlorthalidone Tablets USP, 0.2 mg/ 15 mg. Clonidine HCl and Chlorthalidone Tablets USP, 0.1 mg/ 15 mg. Triamterene and Hydrochlorothiazide Capsules USP, 50 mg/25 mg. E–Z Scrub (chlorhexidine gluconate) Sponge, 4% ......... ANDA 076075 ...................... ANDA 076192 ...................... ANDA 076514 ...................... Econazole Nitrate Cream, 1% ........................................ Ribavirin Capsules USP, 200 mg ................................... Midodrine HCl Tablets USP, 2.5 mg, 5 mg, and 10 mg ANDA 060272 ...................... ANDA 061639 ...................... ANDA 062290 ...................... ANDA 062304 ...................... ANDA 062659 ...................... ANDA 070347 ...................... ANDA 071142 ...................... ANDA 071178 ...................... ANDA 071179 ...................... jbell on DSKJLSW7X2PROD with NOTICES Dated: January 2, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. ANDA 073191 ...................... VerDate Sep<11>2014 17:18 Jan 07, 2020 Jkt 250001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Arbor Pharmaceuticals, LLC. Do. Sanofi-Aventis U.S., LLC, 55 Corporate Dr., Bridgewater, NJ 08807. Par Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY 10977. Do. Do. Do. CASI Pharmaceuticals, Inc., c/o Target Health, Inc., 261 Madison Ave., 24th Floor, New York, NY 10016. Becton, Dickinson and Co., 9450 South State St., Sandy, UT 84070. CASI Pharmaceuticals, Inc., c/o Target Health, Inc. Do. Do. E:\FR\FM\08JAN1.SGM 08JAN1 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

Agencies

[Federal Register Volume 85, Number 5 (Wednesday, January 8, 2020)]
[Notices]
[Pages 909-910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00076]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5550]


Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of 23 abbreviated new drug applications (ANDAs) 
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.

DATES: Approval is withdrawn as of February 7, 2020.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].

SUPPLEMENTARY INFORMATION: 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 described in Sec.  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 Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 040448.................  Phentermine           Elite Laboratories,
                               Hydrochloride (HCl)   Inc., 165 Ludlow
                               Capsules USP, 30      Ave., Northvale, NJ
                               milligrams (mg).      07647.
ANDA 060272.................  E-Mycin               Arbor
                               (erythromycin)        Pharmaceuticals,
                               Delayed-Release       LLC, 6 Concourse
                               Tablets USP, 250 mg   Parkway, Suite
                               and 333 mg.           1800, Atlanta, GA
                                                     30328.
ANDA 061639.................  E.E.S. 200             Do.
                               (erythromycin
                               ethylsuccinate) for
                               Oral Suspension,
                               Equivalent to (EQ)
                               200 mg base/5
                               milliliters
                               (mL).E.E.S. 400
                               (erythromycin
                               ethylsuccinate) for
                               Oral Suspension, EQ
                               400 mg base/5 mL.
ANDA 062290.................  EryDerm               Arbor
                               (erythromycin)        Pharmaceuticals,
                               Topical Solution      LLC.
                               USP, 2%.
ANDA 062304.................  Pediamycin             Do.
                               (erythromycin
                               ethylsuccinate)
                               Oral Suspension
                               USP, EQ 200 mg base/
                               5 mL Pediamycin 400
                               (erythromycin
                               ethylsuccinate)
                               Oral Suspension
                               USP, EQ 400 mg base/
                               5 mL.
ANDA 062659.................  Claforan ADD-Vantage  Sanofi-Aventis U.S.,
                               (cefotaxime) for      LLC, 55 Corporate
                               Injection USP, EQ 1   Dr., Bridgewater,
                               gram (g) base/vial    NJ 08807.
                               and EQ 2 g base/
                               vial.
ANDA 070347.................  Hydro-Ride            Par Pharmaceutical,
                               (amiloride HCl and    Inc., One Ram Ridge
                               hydrochlorothiazide   Rd., Spring Valley,
                               ) Tablets, EQ 5 mg    NY 10977.
                               Anhydrous/50 mg.
ANDA 071142.................  Clonidine HCl and      Do.
                               Chlorthalidone
                               Tablets USP, 0.3 mg/
                               15 mg.
ANDA 071178.................  Clonidine HCl and      Do.
                               Chlorthalidone
                               Tablets USP, 0.2 mg/
                               15 mg.
ANDA 071179.................  Clonidine HCl and      Do.
                               Chlorthalidone
                               Tablets USP, 0.1 mg/
                               15 mg.
ANDA 073191.................  Triamterene and       CASI
                               Hydrochlorothiazide   Pharmaceuticals,
                               Capsules USP, 50 mg/  Inc., c/o Target
                               25 mg.                Health, Inc., 261
                                                     Madison Ave., 24th
                                                     Floor, New York, NY
                                                     10016.
ANDA 073416.................  E-Z Scrub             Becton, Dickinson
                               (chlorhexidine        and Co., 9450 South
                               gluconate) Sponge,    State St., Sandy,
                               4%.                   UT 84070.
ANDA 076075.................  Econazole Nitrate     CASI
                               Cream, 1%.            Pharmaceuticals,
                                                     Inc., c/o Target
                                                     Health, Inc.
ANDA 076192.................  Ribavirin Capsules     Do.
                               USP, 200 mg.
ANDA 076514.................  Midodrine HCl          Do.
                               Tablets USP, 2.5
                               mg, 5 mg, and 10 mg.

[[Page 910]]

 
ANDA 078665.................  Next Choice           Foundation Consumer
                               (levonorgestrel)      Healthcare, LLC,
                               Tablets, 0.75 mg.     1190 Omega Dr.,
                                                     Pittsburgh, PA
                                                     15205.
ANDA 086809.................  Spironolactone        CASI
                               Tablets USP, 25 mg.   Pharmaceuticals,
                                                     Inc., c/o Target
                                                     Health, Inc.
ANDA 087143.................  Acetasol HC           Actavis Mid
                               (hydrocortisone and   Atlantic, LLC,
                               acetic acid) Otic     Subsidiary of Teva
                               Solution USP, 1%      Pharmaceuticals
                               and 2%.               USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 088432.................  Meperidine HCl        ICU Medical, Inc.,
                               Injection USP, 10     600 North Field
                               mg/mL.                Dr., Lake Forest,
                                                     IL 60045.
ANDA 090288.................  Naratriptan Tablets   CASI
                               USP, EQ 1 mg base     Pharmaceuticals,
                               and EQ 2.5 mg base.   Inc., c/o Target
                                                     Health, Inc.
ANDA 091597.................  Gemcitabine for       Sagent
                               Injection USP, EQ     Pharmaceuticals,
                               200 mg base/vial      Inc., 1901 North
                               and EQ 1 g base/      Roselle Rd.,
                               vial.                 Schaumburg, IL
                                                     60195.
ANDA 200670.................  Next Choice One Dose  Foundation Consumer
                               (levonorgestrel)      Healthcare, LLC.
                               Tablets, 1.5 mg.
ANDA 203384.................  Epinastine HCl        CASI
                               Ophthalmic            Pharmaceuticals,
                               Solution, 0.05%.      Inc., c/o Target
                                                     Health, Inc.
------------------------------------------------------------------------

    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.
[FR Doc. 2020-00076 Filed 1-7-20; 8:45 am]
BILLING CODE 4164-01-P


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