Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications, 909-910 [2020-00076]
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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applications be withdrawn.
DATES: Approval is withdrawn as of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 ......................
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17:18 Jan 07, 2020
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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
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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
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]]>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]
-----------------------------------------------------------------------
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
