Mylan Institutional LLC et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications, 13661 [2020-04691]
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Federal Register / Vol. 85, No. 46 / Monday, March 9, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0601]
Mylan Institutional LLC et al.;
Withdrawal of Approval of 16
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
Application No.
Drug
ANDA 040471 ..
Promethazine Hydrochloride (HCl) Injection, 25 milligrams
(mg)/milliliters (mL).
Penicillin G Procaine Injection, 300,000 units/mL and 600,000
units/mL.
Cefazolin Sodium for Injection, Equivalent to (EQ) 10 grams
base/vial.
Azithromycin Oral Suspension, EQ 100 mg base/5 mL; EQ
200 mg base/5 mL.
Dimethyl Sulfoxide Intravesical Solution, 50% .........................
Milrinone Lactate Injection, EQ 1 mg base/mL ........................
Mesna Injection, 100 mg/mL .....................................................
Topiramate Tablets, 25 mg, 50 mg, 100 mg, and 200 mg ......
Stavudine Capsules, 15 mg, 20 mg, 30 mg, and 40 mg .........
ANDA 060286 ..
ANDA 065247 ..
ANDA 065488 ..
ANDA
ANDA
ANDA
ANDA
ANDA
076185
076428
076488
078410
078957
..
..
..
..
..
ANDA 090441 ..
ANDA 200563 ..
ANDA 205657 ..
ANDA 205658 ..
ANDA 200624 ..
ANDA 202384 ..
ANDA 202532 ..
jbell on DSKJLSW7X2PROD with NOTICES
withdrawing approval of 16 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applications be withdrawn.
DATES: Approval is withdrawn as of
April 8, 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.
VerDate Sep<11>2014
17:47 Mar 06, 2020
Jkt 250001
Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL
61103.
Pfizer, Inc., 235 East 42nd St., New York, NY 10017.
Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL
60045.
Lupin Pharmaceuticals, Inc., 111 South Calvert St.,
Harborplace Tower, 21st Floor, Baltimore, MD 21202.
Mylan Institutional LLC.
Do.
Do.
Lupin Pharmaceuticals, Inc.
Hetero USA, Inc., 1035 Centennial Ave., Piscataway, NJ
08854.
Lupin Pharmaceuticals, Inc.
Do.
Mayne Pharma Inc., 1240 Sugg Pkwy., Greenville, NC
27834.
Do.
Lupin Pharmaceuticals, Inc.
Do.
Do.
Dated: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–04691 Filed 3–6–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Organ Transplantation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
SUMMARY:
PO 00000
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:
Applicant
Imipramine HCl Tablets, 10 mg, 25 mg, and 50 mg ................
Ciprofloxacin Oral Suspension, 250 mg/5 mL and 500 mg/5
mL.
Chlorpheniramine Maleate, Hydrocodone Bitartrate, and
Pseudoephedrine HCl Solution, 4 mg/5 mL; 5 mg/5 mL;
and 60 mg/5 mL.
Hydrocodone Bitartrate and Pseudoephedrine HCl Oral Solution, 5 mg/5 mL; and 60 mg/5 mL.
Metformin HCl, and Repaglinide Tablets, 500 mg/1 mg; 500
mg/2 mg.
Omeprazole Delayed-Release Capsules, 40 mg .....................
Clarithromycin Extended-Release Tablets, 500 mg .................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of April 8, 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 April 8, 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.
13661
Frm 00040
Fmt 4703
Sfmt 4703
Advisory Committee on Organ
Transplantation (ACOT) has scheduled
a public meeting. Information about
ACOT and the agenda for this meeting
can be found on the ACOT website at
https://www.organdonor.gov/about-dot/
acot.html.
DATES: April 7, 2020, 8:00 a.m.–4:00
p.m. Eastern Time (ET).
ADDRESSES: This meeting will be held
in-person. The address for the meeting
is 5600 Fishers Lane, Rockville,
Maryland 20857, Room 5A03.
FOR FURTHER INFORMATION CONTACT:
Robert Walsh, Designated Federal
Official, (DFO), at Healthcare Systems
Bureau, Division of Transplantation,
HRSA, 5600 Fishers Lane, 8W60,
Rockville, Maryland 20857; 301–443–
6839; or RWalsh@hrsa.gov.
SUPPLEMENTARY INFORMATION: ACOT
provides advice and recommendations
to the Secretary of HHS (Secretary) on
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 85, Number 46 (Monday, March 9, 2020)]
[Notices]
[Page 13661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04691]
[[Page 13661]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0601]
Mylan Institutional LLC et al.; Withdrawal of Approval of 16
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 16 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 April 8, 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 040471................. Promethazine Mylan Institutional
Hydrochloride (HCl) LLC, 4901 Hiawatha
Injection, 25 Dr., Rockford, IL
milligrams (mg)/ 61103.
milliliters (mL).
ANDA 060286................. Penicillin G Pfizer, Inc., 235
Procaine Injection, East 42nd St., New
300,000 units/mL York, NY 10017.
and 600,000 units/
mL.
ANDA 065247................. Cefazolin Sodium for Hospira, Inc., 275
Injection, North Field Dr.,
Equivalent to (EQ) Bldg. H1, Lake
10 grams base/vial. Forest, IL 60045.
ANDA 065488................. Azithromycin Oral Lupin
Suspension, EQ 100 Pharmaceuticals,
mg base/5 mL; EQ Inc., 111 South
200 mg base/5 mL. Calvert St.,
Harborplace Tower,
21st Floor,
Baltimore, MD
21202.
ANDA 076185................. Dimethyl Sulfoxide Mylan Institutional
Intravesical LLC.
Solution, 50%.
ANDA 076428................. Milrinone Lactate Do.
Injection, EQ 1 mg
base/mL.
ANDA 076488................. Mesna Injection, 100 Do.
mg/mL.
ANDA 078410................. Topiramate Tablets, Lupin
25 mg, 50 mg, 100 Pharmaceuticals,
mg, and 200 mg. Inc.
ANDA 078957................. Stavudine Capsules, Hetero USA, Inc.,
15 mg, 20 mg, 30 1035 Centennial
mg, and 40 mg. Ave., Piscataway,
NJ 08854.
ANDA 090441................. Imipramine HCl Lupin
Tablets, 10 mg, 25 Pharmaceuticals,
mg, and 50 mg. Inc.
ANDA 200563................. Ciprofloxacin Oral Do.
Suspension, 250 mg/
5 mL and 500 mg/5
mL.
ANDA 205657................. Chlorpheniramine Mayne Pharma Inc.,
Maleate, 1240 Sugg Pkwy.,
Hydrocodone Greenville, NC
Bitartrate, and 27834.
Pseudoephedrine HCl
Solution, 4 mg/5
mL; 5 mg/5 mL; and
60 mg/5 mL.
ANDA 205658................. Hydrocodone Do.
Bitartrate and
Pseudoephedrine HCl
Oral Solution, 5 mg/
5 mL; and 60 mg/5
mL.
ANDA 200624................. Metformin HCl, and Lupin
Repaglinide Pharmaceuticals,
Tablets, 500 mg/1 Inc.
mg; 500 mg/2 mg.
ANDA 202384................. Omeprazole Delayed- Do.
Release Capsules,
40 mg.
ANDA 202532................. Clarithromycin Do.
Extended-Release
Tablets, 500 mg.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of April
8, 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 April 8, 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: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04691 Filed 3-6-20; 8:45 am]
BILLING CODE 4164-01-P
