Watson Laboratories, Inc. et al.; Withdrawal of Approval of 36 Abbreviated New Drug Applications, 33718-33719 [2021-13593]
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33718
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
records per
recordkeeper 2
Number of
recordkeepers
21 CFR section; activity
Total
annual
records
Average
burden per
recordkeeping
Total hours
Subpart C: Sales restrictions
203.23(a) and (b); returns .............
2,200
71.9909
158,380
0.25 (15 minutes) ..........................
39,595
203.23(c); documentation of storage of returns.
2,200
71.9909
158,380
0.08 (∼6 minutes) ..........................
12,670
Subpart D: Samples
203.30–203.39; documentation regarding sample distributions.
140
202
28,280
∼.07–.08 (∼4–5 minutes) ...............
2,121
Total ........................................
..........................
..........................
345,040
........................................................
54,386
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Rounded to the nearest whole number.
Based on a review of Agency data, we
assume 2,200 respondents may incur
burden resulting from the information
collection activity associated with the
requirements in § 203.23(a) through (c).
A total of 140 pharmaceutical
companies have submitted information
to the Agency on drug sample
distribution under part 203. Those same
respondents also have recordkeeping
requirements under part 203. Our
estimate of the burden of the average
burden per recordkeeping reflects a
cumulative average to cover all
applicable requirements. Since our last
request for OMB approval, we have
adjusted our estimate of the overall
burden downward to reflect a decrease
of 2,567,713 hours and 64,432,232
records annually. We attribute this
adjustment to a more accurate reflection
of the number of respondents to the
information collection and clarification
that burden attributable to requirements
of the Drug Quality and Security Act are
not included in this information
collection.
[FR Doc. 2021–13597 Filed 6–24–21; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2021–N–0492]
Watson Laboratories, Inc. et al.;
Withdrawal of Approval of 36
Abbreviated New Drug Applications
Food and Drug Administration,
HHS.
ACTION:
Approval is withdrawn as of July
26, 2021.
DATES:
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 36 abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
SUMMARY:
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.
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.
SUPPLEMENTARY INFORMATION:
Application
No.
Drug
Applicant
ANDA 062142 ......
Doxycycline Hyclate Capsules, Equivalent to (EQ) 50 milligrams (mg) base and EQ 200 mg base.
ANDA 062497 ......
Doxycycline Hyclate Capsules, EQ 50 mg base and EQ 100
mg base.
Cephalexin Capsules, EQ 250 mg base and EQ 500 mg
base.
Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace
Pkwy., Building A, Parsippany, NJ 07054.
Teva Pharmaceuticals USA, Inc. 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.
Yung Shin Pharmaceutical Ind. Co. Ltd., authorized U.S.
agent, Carlsbad Technology, Inc./Simon Law, 5922
Farnsworth Ct., Suite 101, Carlsbad, CA 92008.
Watson Laboratories, Inc.
Do.
IVAX Pharmaceuticals Inc. (an indirect wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace
Pkwy., Building A, Parsippany, NJ 07054.
Do.
Watson Laboratories, Inc.
Do.
Do.
Do.
ANDA 065152 ......
lotter on DSK11XQN23PROD with NOTICES1
Dated: June 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
ANDA 070550 ......
ANDA 070551 ......
ANDA 070943 ......
Propranolol Hydrochloride (HCl) Tablets, 40 mg ....................
Propranolol HCl Tablets, 80 mg ..............................................
Oxazepam Capsules, 10 mg ...................................................
ANDA
ANDA
ANDA
ANDA
ANDA
Oxazepam Capsules, 30 mg ...................................................
Temazepam Capsules, 15 mg ................................................
Temazepam Capsules, 30 mg ................................................
Oxazepam Capsules, 10 mg ...................................................
Baclofen Tablets, 10 mg .........................................................
070945
071446
071447
072952
073092
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......
......
......
......
18:38 Jun 24, 2021
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Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices
Application
No.
Drug
Applicant
ANDA 074400 ......
ANDA 074432 ......
Diflunisal Tablets, 250 mg and 500 mg ..................................
Diclofenac Sodium Delayed Release Tablets, 50 mg and 75
mg.
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
......
......
......
......
......
......
Piroxicam Capsules, 10 mg and 20 mg ..................................
Indapamide Tablets, 1.25 mg and 2.5 mg ..............................
Baclofen Tablets, 10 mg and 20 mg .......................................
Mexiletine HCl Capsules, 150 mg, 200 mg and 250 mg ........
Diclofenac Sodium Delayed Release Tablets, 50 mg ............
Diltiazem HCl Extended Release Capsules, 120 mg, 180
mg, and 240 mg.
ANDA 074865 ......
ANDA 074870 ......
Mexiletine HCl Capsules, 150 mg, 200 mg, and 250 mg .......
Acyclovir Tablets, 400 mg and 800 mg ..................................
ANDA 075101 ......
ANDA 076022 ......
Acyclovir Capsules, 200 mg ....................................................
Fluoxetine HCl Capsules, EQ 10 mg base and EQ 20 mg
base.
Prednisolone Sodium Phosphate Solution, EQ 15 mg base/5
milliliters (mL).
Isoniazid Tablets, 300 mg .......................................................
Nitroglycerin Controlled-Release Capsules, 6.5 mg ...............
Do.
Pliva, Inc. (an indirect, wholly owned subsidiary of Teva
Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building
A, Parsippany, NJ 07054.
Watson Laboratories, Inc.
Do.
Do.
Do.
Teva Pharmaceuticals USA, Inc.
Actavis Laboratories FL, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace
Pkwy., Building A, Parsippany, NJ 07054.
Watson Laboratories, Inc.
Actavis Elizabeth LLC (an indirect, wholly owned subsidiary
of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy.,
Building A, Parsippany, NJ 07054.
Watson Laboratories, Inc.
Carlsbad Technology, Inc., 5922 Farnsworth Ct., Carlsbad,
CA 92008.
Amneal Pharmaceuticals, 85 Adams Ave., Hauppauge, NY
11788.
Watson Laboratories, Inc.
Lumara Health, Inc., 1100 Winter St., Suite 3000, Waltham,
MA 02451.
Watson Laboratories, Inc.
Watson Laboratories, Inc.
Sandoz Inc., 100 College Rd. West, Princeton, NJ 08540.
Do.
Do.
Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC.,
6451 Main St., Morton Grove, IL 60053.
074460
074585
074698
074711
074723
074852
ANDA 078345 ......
ANDA 080521 ......
ANDA 086537 ......
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
086889
086890
087975
087976
088509
090833
......
......
......
......
......
......
ANDA 200771 ......
ANDA 202063 ......
lotter on DSK11XQN23PROD with NOTICES1
33719
Disulfiram Tablets, 250 mg .....................................................
Disulfiram Tablets, 500 mg .....................................................
Nitroglycerin Controlled-Release Capsules, 2.5 mg ...............
Nitroglycerin Controlled-Release Capsules, 6.5 mg ...............
Nitroglycerin Controlled-Release Capsules, 9 mg ..................
Carbidopa/Levodopa and Entacapone Tablets, 18.75 mg/
200 mg/75 mg, 25 mg/200 mg/100 mg, 31.25 mg/200 mg/
125 mg, 37.5 mg/200 mg/150 mg, and 50 mg/200 mg/200
mg.
Irinotecan HCl Injection, 40 mg/2 mL (20 mg/mL) and 100
mg/5 mL (20 mg/mL).
ANDA 204437 ......
Gemcitabine HCl for Injection, EQ 200 mg base/vial; EQ 1
gram base/vial.
Sodium Fluoride 18 Injection, 10–200 millicurie (mCi)/mL .....
ANDA 208444 ......
Choline C–11 Injection, 4–33.1 mCi/mL .................................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of July 26, 2021.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms 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 July 26, 2021 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.
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Heritage Pharmaceuticals Inc. d/b/a/Avet Pharmaceuticals
Inc. U.S. Agent for Emcure Pharmaceuticals Limited, One
Tower Center Blvd., East Brunswick, NJ 08816.
Do.
UCSF Radiopharmaceutical Facility, 185 Berry St., Suite
350, San Francisco, CA 94107.
Do.
Dated: June 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–13593 Filed 6–24–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Secretary; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Interagency Autism
Coordinating Committee.
The meeting will be held as a virtual
meeting and is open to the public.
Individuals who plan to view the virtual
meeting and need special assistance or
other reasonable accommodations to
view the meeting, should notify the
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
Contact Person listed below in advance
of the meeting. The open session will be
videocast and can be accessed from the
NIH Videocasting and Podcasting
website (https://videocast.nih.gov/).
Name of Committee: Interagency Autism
Coordinating Committee.
Date: July 21–22, 2021.
Time: Wednesday, July 21, 2021—1:00
p.m. to 4:00 p.m. ET, https://
videocast.nih.gov/watch=42326; Thursday,
July 22, 2021—2:00 p.m. to 5:00 p.m. ET,
https://videocast.nih.gov/watch=42327.
Agenda: To discuss business, updates, and
issues related to ASD research and services
activities.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Cost: The meeting is free and open to the
public.
Registration: A registration web link will
be posted on the IACC website
(www.iacc.hhs.gov) prior to the meeting. Preregistration is recommended.
Deadlines: Written/Virtual Public
Comment Due Date: Friday, July 2, 2021, by
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]]>Agencies
[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33718-33719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13593]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0492]
Watson Laboratories, Inc. et al.; Withdrawal of Approval of 36
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 36 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 July 26, 2021.
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 062142................. Doxycycline Hyclate Watson Laboratories,
Capsules, Inc. (an indirect,
Equivalent to (EQ) wholly owned
50 milligrams (mg) subsidiary of Teva
base and EQ 200 mg Pharmaceuticals
base. USA, Inc.), 400
Interpace Pkwy.,
Building A,
Parsippany, NJ
07054.
ANDA 062497................. Doxycycline Hyclate Teva Pharmaceuticals
Capsules, EQ 50 mg USA, Inc. 400
base and EQ 100 mg Interpace Pkwy.,
base. Building A,
Parsippany, NJ
07054.
ANDA 065152................. Cephalexin Capsules, Yung Shin
EQ 250 mg base and Pharmaceutical Ind.
EQ 500 mg base. Co. Ltd.,
authorized U.S.
agent, Carlsbad
Technology, Inc./
Simon Law, 5922
Farnsworth Ct.,
Suite 101,
Carlsbad, CA 92008.
ANDA 070550................. Propranolol Watson Laboratories,
Hydrochloride (HCl) Inc.
Tablets, 40 mg.
ANDA 070551................. Propranolol HCl Do.
Tablets, 80 mg.
ANDA 070943................. Oxazepam Capsules, IVAX Pharmaceuticals
10 mg. Inc. (an indirect
wholly owned
subsidiary of Teva
Pharmaceuticals
USA, Inc.), 400
Interpace Pkwy.,
Building A,
Parsippany, NJ
07054.
ANDA 070945................. Oxazepam Capsules, Do.
30 mg.
ANDA 071446................. Temazepam Capsules, Watson Laboratories,
15 mg. Inc.
ANDA 071447................. Temazepam Capsules, Do.
30 mg.
ANDA 072952................. Oxazepam Capsules, Do.
10 mg.
ANDA 073092................. Baclofen Tablets, 10 Do.
mg.
[[Page 33719]]
ANDA 074400................. Diflunisal Tablets, Do.
250 mg and 500 mg.
ANDA 074432................. Diclofenac Sodium Pliva, Inc. (an
Delayed Release indirect, wholly
Tablets, 50 mg and owned subsidiary of
75 mg. Teva
Pharmaceuticals
USA, Inc.), 400
Interpace Pkwy.,
Building A,
Parsippany, NJ
07054.
ANDA 074460................. Piroxicam Capsules, Watson Laboratories,
10 mg and 20 mg. Inc.
ANDA 074585................. Indapamide Tablets, Do.
1.25 mg and 2.5 mg.
ANDA 074698................. Baclofen Tablets, 10 Do.
mg and 20 mg.
ANDA 074711................. Mexiletine HCl Do.
Capsules, 150 mg,
200 mg and 250 mg.
ANDA 074723................. Diclofenac Sodium Teva Pharmaceuticals
Delayed Release USA, Inc.
Tablets, 50 mg.
ANDA 074852................. Diltiazem HCl Actavis Laboratories
Extended Release FL, Inc. (an
Capsules, 120 mg, indirect, wholly
180 mg, and 240 mg. owned subsidiary of
Teva
Pharmaceuticals
USA, Inc.), 400
Interpace Pkwy.,
Building A,
Parsippany, NJ
07054.
ANDA 074865................. Mexiletine HCl Watson Laboratories,
Capsules, 150 mg, Inc.
200 mg, and 250 mg.
ANDA 074870................. Acyclovir Tablets, Actavis Elizabeth
400 mg and 800 mg. LLC (an indirect,
wholly owned
subsidiary of Teva
Pharmaceuticals
USA, Inc.), 400
Interpace Pkwy.,
Building A,
Parsippany, NJ
07054.
ANDA 075101................. Acyclovir Capsules, Watson Laboratories,
200 mg. Inc.
ANDA 076022................. Fluoxetine HCl Carlsbad Technology,
Capsules, EQ 10 mg Inc., 5922
base and EQ 20 mg Farnsworth Ct.,
base. Carlsbad, CA 92008.
ANDA 078345................. Prednisolone Sodium Amneal
Phosphate Solution, Pharmaceuticals, 85
EQ 15 mg base/5 Adams Ave.,
milliliters (mL). Hauppauge, NY
11788.
ANDA 080521................. Isoniazid Tablets, Watson Laboratories,
300 mg. Inc.
ANDA 086537................. Nitroglycerin Lumara Health, Inc.,
Controlled-Release 1100 Winter St.,
Capsules, 6.5 mg. Suite 3000,
Waltham, MA 02451.
ANDA 086889................. Disulfiram Tablets, Watson Laboratories,
250 mg. Inc.
ANDA 086890................. Disulfiram Tablets, Watson Laboratories,
500 mg. Inc.
ANDA 087975................. Nitroglycerin Sandoz Inc., 100
Controlled-Release College Rd. West,
Capsules, 2.5 mg. Princeton, NJ
08540.
ANDA 087976................. Nitroglycerin Do.
Controlled-Release
Capsules, 6.5 mg.
ANDA 088509................. Nitroglycerin Do.
Controlled-Release
Capsules, 9 mg.
ANDA 090833................. Carbidopa/Levodopa Morton Grove
and Entacapone Pharmaceuticals
Tablets, 18.75 mg/ Inc./Wockhardt USA
200 mg/75 mg, 25 mg/ LLC., 6451 Main
200 mg/100 mg, St., Morton Grove,
31.25 mg/200 mg/125 IL 60053.
mg, 37.5 mg/200 mg/
150 mg, and 50 mg/
200 mg/200 mg.
ANDA 200771................. Irinotecan HCl Heritage
Injection, 40 mg/2 Pharmaceuticals
mL (20 mg/mL) and Inc. d/b/a/Avet
100 mg/5 mL (20 mg/ Pharmaceuticals
mL). Inc. U.S. Agent for
Emcure
Pharmaceuticals
Limited, One Tower
Center Blvd., East
Brunswick, NJ
08816.
ANDA 202063................. Gemcitabine HCl for Do.
Injection, EQ 200
mg base/vial; EQ 1
gram base/vial.
ANDA 204437................. Sodium Fluoride 18 UCSF
Injection, 10-200 Radiopharmaceutical
millicurie (mCi)/mL. Facility, 185 Berry
St., Suite 350, San
Francisco, CA
94107.
ANDA 208444................. Choline C-11 Do.
Injection, 4-33.1
mCi/mL.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of July
26, 2021. Approval of each entire application is withdrawn, including
any strengths and dosage forms 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 July 26, 2021 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: June 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13593 Filed 6-24-21; 8:45 am]
BILLING CODE 4164-01-P
