Wockhardt Ltd., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications, 64150 [2020-22403]
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64150
Federal Register / Vol. 85, No. 197 / Friday, October 9, 2020 / Notices
withdrawing approval of nine
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withdrawn.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1866]
Wockhardt Ltd., et al.; Withdrawal of
Approval of Nine Abbreviated New
Drug Applications
AGENCY:
Approval is withdrawn as of
November 9, 2020.
DATES:
Food and Drug Administration,
HHS.
FOR FURTHER INFORMATION CONTACT:
ACTION:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
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 040533 ......................
Bethanechol Chloride Tablets, 10 milligrams (mg) .........
ANDA 040534 ......................
ANDA 075015 ......................
Bethanechol Chloride Tablets, 25 mg ............................
Acyclovir Sodium for Injection, Equivalent to (EQ) 500
mg base/vial.
Pamidronate Disodium for Injection, 30 mg/vial, and 90
mg/vial.
Calcitriol Injection, 0.001 mg/milliliter (mL) .....................
Morton Grove Pharmaceuticals Inc./Wockhardt USA
LLC, 6451 Main St., Morton Grove, IL 60053.
Do.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake
Zurich, IL 60047.
Do.
ANDA 075773 ......................
ANDA 076206 ......................
ANDA 076207 ......................
ANDA 077788 ......................
ANDA 077990 ......................
Pamidronate Disodium Injection, 30 mg/10 mL (3 mg/
mL) and 90 mg/mL (9 mg/mL).
Albuterol Sulfate Syrup, EQ 2 mg base/5 mL ................
Zolpidem Tartrate Tablets, 5 mg and 10 mg ..................
ANDA 202410 ......................
Donepezil Hydrochloride Tablets, 23 mg ........................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of November 9,
2020. 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 November 9,
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: October 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–22403 Filed 10–8–20; 8:45 am]
Rockwell Medical, Inc., 30142 S. Wixom Rd., Wixom,
MI 48393.
Fresenius Kabi USA, LLC.
VistaPharm, Inc., 7265 Ulmerton Rd., Largo, FL 33771.
Carlsbad Technology, Inc., U.S. Agent for Yung Shin
Pharmaceutical Industrial Co., Ltd., 4761 Tara Ct.,
West Bloomfield, MI 48323.
Hisun Pharmaceutical (Hangzhou) Co., Ltd., U.S.
Agent, Hisun Pharmaceuticals USA, Inc., 200 Crossing Blvd., 2nd floor, Bridgewater, NJ 08807.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1867]
Novartis Pharmaceuticals Corp., et al.;
Withdrawal of Approval of 13 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 13 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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
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, Kimberly.Lehrfeld@
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:
Approval is withdrawn as of
November 9, 2020.
DATES:
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[Federal Register Volume 85, Number 197 (Friday, October 9, 2020)]
[Notices]
[Page 64150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22403]
[[Page 64150]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1866]
Wockhardt Ltd., et al.; Withdrawal of Approval of Nine
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 nine 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 November 9, 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 040533................. Bethanechol Chloride Morton Grove
Tablets, 10 Pharmaceuticals
milligrams (mg). Inc./Wockhardt USA
LLC, 6451 Main St.,
Morton Grove, IL
60053.
ANDA 040534................. Bethanechol Chloride Do.
Tablets, 25 mg.
ANDA 075015................. Acyclovir Sodium for Fresenius Kabi USA,
Injection, LLC, Three
Equivalent to (EQ) Corporate Dr., Lake
500 mg base/vial. Zurich, IL 60047.
ANDA 075773................. Pamidronate Disodium Do.
for Injection, 30
mg/vial, and 90 mg/
vial.
ANDA 076206................. Calcitriol Rockwell Medical,
Injection, 0.001 mg/ Inc., 30142 S.
milliliter (mL). Wixom Rd., Wixom,
MI 48393.
ANDA 076207................. Pamidronate Disodium Fresenius Kabi USA,
Injection, 30 mg/10 LLC.
mL (3 mg/mL) and 90
mg/mL (9 mg/mL).
ANDA 077788................. Albuterol Sulfate VistaPharm, Inc.,
Syrup, EQ 2 mg base/ 7265 Ulmerton Rd.,
5 mL. Largo, FL 33771.
ANDA 077990................. Zolpidem Tartrate Carlsbad Technology,
Tablets, 5 mg and Inc., U.S. Agent
10 mg. for Yung Shin
Pharmaceutical
Industrial Co.,
Ltd., 4761 Tara
Ct., West
Bloomfield, MI
48323.
ANDA 202410................. Donepezil Hisun Pharmaceutical
Hydrochloride (Hangzhou) Co.,
Tablets, 23 mg. Ltd., U.S. Agent,
Hisun
Pharmaceuticals
USA, Inc., 200
Crossing Blvd., 2nd
floor, Bridgewater,
NJ 08807.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
November 9, 2020. 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 November 9, 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: October 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22403 Filed 10-8-20; 8:45 am]
BILLING CODE 4164-01-P
