[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Notices]
[Pages 8598-8599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03025]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5608]
Wockhardt Limited, et al.; Withdrawal of Approval of 28
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 28 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of March 16, 2020.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.
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Application No. Drug Applicant
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ANDA 040732................. Phenytoin Sodium Wockhardt Limited, c/
Capsules, 100 o Morton Grove
milligrams (mg) Pharmaceuticals,
(Extended). Inc., 6451 Main
St., Morton Grove,
IL 60053.
ANDA 065230................. Ceftriaxone for Hospira, Inc., 275
Injection, North Field Dr.,
Equivalent to (EQ) Bldg. H1, Lake
250 mg base/vial; Forest, IL 60045.
EQ 500 mg base/
vial; EQ 1 gram (g)
base/vial; EQ 2 g
base/vial.
ANDA 065231................. Ceftriaxone for Do.
Injection, EQ 1 g
base/vial; EQ 2 g
base/vial Piggy
Back.
ANDA 065290................. Cefotaxime Sodium Do.
for Injection, EQ
500 mg base/vial;
EQ 1 g base/vial;
EQ 2 g base/vial.
ANDA 065292................. Cefotaxime Sodium Do.
for Injection, EQ
10 g base/vial
Pharmacy Bulk
Package.
ANDA 065293................. Cefotaxime Sodium Do.
for Injection, EQ 1
g base/vial; EQ 2 g
base/vial.
ANDA 065312................. Cefoxitin for Do.
Injection, EQ 10 g
base/vial Pharmacy
Bulk Package.
ANDA 065313................. Cefoxitin for Do.
Injection, EQ 1 g
base/vial; EQ 2 g
base/vial.
ANDA 065369................. Cefepime Do.
Hydrochloride (HCl)
for Injection, EQ
500 mg base/vial;
EQ 1 g base/vial;
EQ 2 g base/vial.
ANDA 065483................. Cefuroxime Sodium Do.
for Injection, EQ
750 mg base/vial;
EQ 1.5 g base/vial.
[[Page 8599]]
ANDA 065484................. Cefuroxime Sodium Do.
for Injection, EQ
7.5 g base/vial
Pharmacy Bulk
Package.
ANDA 065503................. Cefuroxime Sodium Do.
for Injection, EQ
1.5 g base/vial.
ANDA 075250................. Prednisolone Sodium Bausch Health US,
Phosphate Oral LLC, 400 Somerset
Solution, EQ 15 mg Corporate Blvd.,
base/5 milliliters Bridgewater, NJ
(mL). 08807.
ANDA 075618................. Acetaminophen, Hikma
Butalbital, Pharmaceuticals USA
Caffeine, and Inc., 1809 Wilson
Codeine Phosphate Rd., Columbus, OH
Capsules, 325 mg, 43228.
50 mg, 40 mg, and
30 mg.
ANDA 090375................. Ampicillin and Hospira, Inc.
Sulbactam for
Injection, EQ 1 g
base/vial and EQ
500 mg base/vial;
EQ 2 g base/vial
and EQ 1 g base/
vial.
ANDA 090646................. Ampicillin and Do.
Sulbactam for
Injection, EQ 10 g
base/vial and EQ 5
g base/vial.
ANDA 090653................. Ampicillin and Do.
Sulbactam for
Injection, EQ 1 g
base/vial and EQ
500 mg base/vial;
EQ 2 g base/vial
and EQ 1 g base/
vial.
ANDA 090825................. Imipenem and Do.
Cilastatin for
Injection, EQ 250
mg base/vial and
250 mg base/vial;
EQ 500 mg base/vial
and 500 mg/vial.
ANDA 090940................. Meropenem for Do.
Injection, 500 mg/
vial, and 1 g/vial.
ANDA 091007................. Imipenem and Do.
Cilastatin for
Injection, EQ 500
mg base/vial and
500 mg/vial.
ANDA 202268................. Cefepime HCl for Do.
Injection, EQ 1 g
base/vial; EQ 2 g
base/vial.
ANDA 202563................. Ceftriaxone for Do.
Injection, EQ 1 g
base/vial; EQ 2 g
base/vial.
ANDA 202864................. Ampicillin Sodium Do.
for Injection, EQ
250 mg base/vial;
EQ 500 mg base/
vial; EQ 1 g base/
vial; EQ 2 g base/
vial.
ANDA 202865................. Ampicillin Sodium Do.
for Injection, EQ
10 g base/vial
Pharmacy Bulk
Package.
ANDA 203132................. Cefotaxime Sodium Do.
for Injection, EQ 1
g base/vial; EQ 2 g
base/vial.
ANDA 204879................. Pyridoxine HCl Mylan Institutional,
Injection, 100 mg/ LLC, 4901 Hiawatha
mL. Dr., Rockford, IL
61103.
ANDA 206062................. Doxorubicin HCl for Hisun Pharmaceutical
Injection, USP, 20 Hangzhou Co., LTD,
mg/vial. 200 Crossing Blvd.,
2nd Floor,
Bridgewater, NJ
08807.
ANDA 206195................. Daunorubicin HCl for Do.
Injection, EQ 20 mg
base/vial.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of March
16, 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 March 16, 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: February 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03025 Filed 2-13-20; 8:45 am]
BILLING CODE 4164-01-P