VistaPharm, Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications, 80119 [2020-27303]
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80119
Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices
interstate commerce, but not later than
March 11, 2021.
Dated: December 7, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–27197 Filed 12–10–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2197]
VistaPharm, Inc., et al.; Withdrawal of
Approval of 10 Abbreviated New Drug
Applications
AGENCY:
Food and Drug Administration,
jbell on DSKJLSW7X2PROD with NOTICES
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 10 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applications be withdrawn.
DATES: Approval is withdrawn as of
January 11, 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, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
applicants listed in the table have
SUMMARY:
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 040323 .................................
Prednisolone Syrup, 15 milligrams (mg)/5 milliliters (mL) .....................
ANDA 075782 .................................
ANDA 076188 .................................
Valproic Acid Syrup, 250 mg/5 mL ........................................................
Fosinopril Sodium Tablets, 10 mg, 20 mg, and 40 mg .........................
ANDA 076189 .................................
ANDA 077537 .................................
Mirtazapine Tablets, 15 mg, 30 mg, and 45 mg ...................................
Glyburide Tablets, 1.25 mg, 2.5 mg, and 5 mg ....................................
ANDA 077672 .................................
ANDA 085055 .................................
ANDA 087266 .................................
Stavudine Capsules, 15 mg, 20 mg, 30 mg, and 40 mg ......................
Tylenol W/Codeine No. 1 (acetaminophen and codeine phosphate)
Tablets, 300 mg; 7.5 mg.
Tylenol W/Codeine No. 2 (acetaminophen and codeine phosphate)
Tablets, 300 mg; 15 mg.
Tylenol W/Codeine No. 3 (acetaminophen and codeine phosphate)
Tablets, 300 mg; 30 mg.
Tylenol W/Codeine No. 4 (acetaminophen and codeine phosphate)
Tablets, 300 mg; 60 mg.
Lindane Shampoo, 1% ..........................................................................
VistaPharm, Inc., 7265 Ulmerton
Rd., Largo, FL 33771
Do.
Upsher-Smith Laboratories, LLC,
6701 Evenstad Dr., Maple
Grove, MN 55369
Do.
Aurobindo Pharma USA, Inc., 279
Princeton-Hightstown Rd., East
Windsor, NJ 08520
Do.
Janssen Pharmaceuticals, Inc.,
1000 U.S. Route 202, P.O. Box
300, Raritan NJ 08869
ANDA 087313 .................................
ANDA 089003 .................................
Lindane Lotion, 1% ................................................................................
Phenytoin Sodium Injection, 50 mg/mL .................................................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of January 11,
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 January 11,
2021 may continue to be dispensed
VerDate Sep<11>2014
23:25 Dec 10, 2020
Jkt 253001
Olta Pharmaceuticals Corp. (an
Akorn Company), 1925 West
Field Ct., Suite 300, Lake Forest, IL 60045
Do.
Fresenius Kabi USA, LLC, Three
Corporate Dr., Lake Zurich, IL
60047
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 8, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[Docket No. FDA–2010–D–0529]
[FR Doc. 2020–27303 Filed 12–10–20; 8:45 am]
Qualification Process for Drug
Development Tools; Guidance for
Industry; Availability; Correction
AGENCY:
BILLING CODE 4160–01–P
PO 00000
Food and Drug Administration
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is correcting a
notice entitled ‘‘Qualification Process
SUMMARY:
Frm 00130
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]]>Agencies
[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Page 80119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27303]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2197]
VistaPharm, Inc., et al.; Withdrawal of Approval of 10
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 10 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 January 11, 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 040323................... Prednisolone Syrup, 15 VistaPharm,
milligrams (mg)/5 Inc., 7265
milliliters (mL). Ulmerton Rd.,
Largo, FL 33771
ANDA 075782................... Valproic Acid Syrup, Do.
250 mg/5 mL.
ANDA 076188................... Fosinopril Sodium Upsher-Smith
Tablets, 10 mg, 20 Laboratories,
mg, and 40 mg. LLC, 6701
Evenstad Dr.,
Maple Grove, MN
55369
ANDA 076189................... Mirtazapine Tablets, Do.
15 mg, 30 mg, and 45
mg.
ANDA 077537................... Glyburide Tablets, Aurobindo Pharma
1.25 mg, 2.5 mg, and USA, Inc., 279
5 mg. Princeton-
Hightstown Rd.,
East Windsor,
NJ 08520
ANDA 077672................... Stavudine Capsules, 15 Do.
mg, 20 mg, 30 mg, and
40 mg.
ANDA 085055................... Tylenol W/Codeine No. Janssen
1 (acetaminophen and Pharmaceuticals
codeine phosphate) , Inc., 1000
Tablets, 300 mg; 7.5 U.S. Route 202,
mg. P.O. Box 300,
Tylenol W/Codeine No. Raritan NJ
2 (acetaminophen and 08869
codeine phosphate)
Tablets, 300 mg; 15
mg.
Tylenol W/Codeine No.
3 (acetaminophen and
codeine phosphate)
Tablets, 300 mg; 30
mg.
Tylenol W/Codeine No.
4 (acetaminophen and
codeine phosphate)
Tablets, 300 mg; 60
mg.
ANDA 087266................... Lindane Shampoo, 1%... Olta
Pharmaceuticals
Corp. (an Akorn
Company), 1925
West Field Ct.,
Suite 300, Lake
Forest, IL
60045
ANDA 087313................... Lindane Lotion, 1%.... Do.
ANDA 089003................... Phenytoin Sodium Fresenius Kabi
Injection, 50 mg/mL. USA, LLC, Three
Corporate Dr.,
Lake Zurich, IL
60047
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 11, 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 January 11, 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: December 8, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27303 Filed 12-10-20; 8:45 am]
BILLING CODE 4160-01-P
