Facta Farmaceutici S.p.A., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications, 1745-1746 [2019-01129]
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Federal Register / Vol. 84, No. 24 / Tuesday, February 5, 2019 / Notices
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1745
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Dated: January 16, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019–01067 Filed 2–4–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0113]
Facta Farmaceutici S.p.A., et al.;
Withdrawal of Approval of 23
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 23 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applications be withdrawn.
DATES: Approval is withdrawn as of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 7, 2019.
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1671, Silver Spring,
MD 20993–0002, 240–402–7945,
Trang.Tran@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.
SUMMARY:
Application No.
Drug
Applicant
ANDA 062117 .........
Facta Farmaceutici S.p.A., c/o Interchem Corp., 120 Route,
17 North, Paramus, NJ 07652.
ANDA 062508 .........
Cephalexin for Oral Suspension USP, Equivalent to (EQ)
100 milligrams (mg) base/milliliter (mL), EQ 125 mg
base/5 mL, and EQ 250 mg base/5 mL.
Erymax (erythromycin) Topical Solution USP, 2% ...............
ANDA 075369 .........
Enalapril Maleate Tablets USP, 10 mg and 20 mg ..............
ANDA 075370 .........
Enalapril Maleate Tablets USP, 2.5 mg and 5 mg ...............
VerDate Sep<11>2014
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Merz North America, 6501 Six Forks Rd., Raleigh, NC
27615.
Krka, tovarna zdravil, d.d., Novo mesto, Slovenia, c/o
KRKA USA, LLC, 4216 Cravens Point Rd., Wilmington,
NC 28409.
Do.
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1746
Federal Register / Vol. 84, No. 24 / Tuesday, February 5, 2019 / Notices
Application No.
Drug
Applicant
ANDA 077895 .........
Ursodiol Capsules USP, 300 mg ..........................................
ANDA 078810 .........
Oxaliplatin for Injection, 50 mg/vial and 100 mg/vial ............
ANDA 080420 .........
ANDA 080421 .........
ANDA 083083 .........
Lidocaine Hydrochloride (HCl) Injection USP, 1%, 1.5%,
and 2%.
Procaine HCl Injection USP, 1% and 2% .............................
Lidocaine HCl Injection USP, 1% and 2% ............................
ANDA 083744 .........
Lidocaine HCl Injection USP, 0.5%, 1%, 1.5%, and 2% ......
ANDA 083907 .........
ANDA 084571 .........
Lidocaine HCl With Epinephrine Injection USP ....................
Lidocaine HCl Injection, 10 mg/20 mL and 10 mg/50 mL ....
ANDA 084572 .........
ANDA 084720 .........
Lidocaine HCl Injection, 20 mg/20 mL and 20 mg/50 mL ....
Lidocaine HCl and Epinephrine Injection USP, 2%; 0.01
mg/mL.
Lidocaine HCl and Epinephrine Injection USP, 2%; 0.02
mg/mL.
Alphacaine (lidocaine) Ointment, 5% ....................................
Impax Laboratories, LLC, 30831 Huntwood Ave., Hayward,
CA 94544.
Fresenius Kabi Oncology Plc., c/o Fresenius Kabi USA,
LLC, Three Corporate Dr., Lake Zurich, IL 60047.
Lyphomed, Inc., 2045 North Cornell Ave., Melrose Park, IL
60160.
Do.
Wyeth-Ayerst Laboratories, P.O. Box 8299, Philadelphia,
PA 19101.
Tera Pharmaceuticals, Inc., 6920 Stanton Ave., Buena
Park, CA 90621.
Do.
Knoll Pharmaceuticals, 30 North Jefferson Rd., Whippany,
NJ 07981.
Do.
Naska Pharmacal Co., Inc., Riverview Rd., P.O. Box 898,
Lincolnton, NC 28093.
Do.
ANDA 084732 .........
ANDA 084947 .........
ANDA 085037 .........
ANDA 085677 .........
ANDA 088051 .........
Lidocaine HCl Injection USP, 1% and 2% ............................
Cortisone Acetate Injectable Suspension USP, 25 mg/mL
and 50 mg/mL.
Thalitone (chlorthalidone) Tablets USP, 25 mg ....................
ANDA 089688 .........
Lidocaine HCl Topical Solution USP, 4% .............................
ANDA 091212 .........
Lansoprazole Delayed-Release Capsules USP, 15 mg and
30 mg.
Vancomycin HCl for Injection USP, EQ 500 mg base/vial
and EQ 1gram (g) base/vial.
Vancomycin HCl for Injection USP, EQ 5 g base/vial and
EQ 10 g base/vial (Pharmacy Bulk Package).
ANDA 091377 .........
ANDA 206243 .........
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of March 7,
2019. 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 7, 2019,
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: January 16, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019–01129 Filed 2–4–19; 8:45 am]
BILLING CODE 4164–01–P
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Carlisle Laboratories, Inc., 404 Doughty Blvd., Inwood, NY
11696.
Akorn, Inc., P.O. Box 1220, Decatur, IL 62525.
Steris Laboratories, Inc., 620 North 51st Ave., Phoenix, AZ
85043.
Casper Pharma LLC, 2 Tower Center Blvd., Suite 1101C,
East Brunswick, NJ 08816.
Paco Research, Corp., 1705 Oak St., Lakewood, NJ
08701.
Krka, tovarna zdravil, d.d., Novo mesto, c/o KRKA USA,
LLC.
Xellia Pharmaceuticals ApS, c/o Xellia Pharmaceuticals
USA, LLC, 8841 Wadford Dr., Raleigh, NC 27616.
Do.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1987–D–0240 (formerly
87D–0315)]
Neomycin Sulfate for Prescription
Compounding; Withdrawal of Approval
of One Abbreviated New Drug
Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of abbreviated
new drug application (ANDA) 061579
for nonsterile neomycin sulfate powder
for prescription compounding. The
basis for the withdrawal is that the
product is no longer considered safe as
labeled due to clinical evidence that
systemic exposure to neomycin sulfate
can induce significant toxicity,
including ototoxicity (manifested as
sensorineural hearing loss),
nephrotoxicity, and neuromuscular
blockade. The holder of this ANDA has
waived its opportunity for a hearing.
DATES: Approval is withdrawn as of
February 5, 2019.
SUMMARY:
PO 00000
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Kate
Greenwood, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6286, Silver Spring,
MD 20993–0002, 240–402–1748.
SUPPLEMENTARY INFORMATION: In the
Federal Register of April 15, 1988, FDA
published four documents arising out of
the Agency’s finding that systemic
absorption of neomycin sulfate can
induce significant toxicity, including
ototoxicity (manifested as sensorineural
hearing loss), nephrotoxicity, and
neuromuscular blockade (see generally
53 FR 12644; 53 FR 12658; 53 FR 12662;
and 53 FR 12664 (April 15, 1988)). Two
of the four documents were issued
under docket numbers FDA–1979–N–
0220 and FDA–1987–D–0240 and
related to nonsterile neomycin sulfate
for prescription compounding.1
Under docket number FDA–1979–N–
0220, FDA published a final rule
amending the antibiotic drug
FOR FURTHER INFORMATION CONTACT:
1 These documents were originally assigned
docket numbers 79N–0155, and 87D–0315. The
numbers were changed to FDA–1979–N–0220 and
FDA–1987–D–0240, respectively, as a result of
FDA’s transition to its new docketing system
(Regulations.gov) in January 2008. The other two
documents were issued under docket number FDA–
1979–N–0256 (formerly 79N–0151) and related to
neomycin sulfate in sterile vials for parenteral use.
E:\FR\FM\05FEN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 24 (Tuesday, February 5, 2019)]
[Notices]
[Pages 1745-1746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01129]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0113]
Facta Farmaceutici S.p.A., et al.; Withdrawal of Approval of 23
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 23 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 7, 2019.
FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945,
Trang.Tran@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 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 062117............... Cephalexin for Oral Facta Farmaceutici
Suspension USP, S.p.A., c/o
Equivalent to (EQ) Interchem Corp., 120
100 milligrams (mg) Route, 17 North,
base/milliliter Paramus, NJ 07652.
(mL), EQ 125 mg base/
5 mL, and EQ 250 mg
base/5 mL.
ANDA 062508............... Erymax (erythromycin) Merz North America,
Topical Solution 6501 Six Forks Rd.,
USP, 2%. Raleigh, NC 27615.
ANDA 075369............... Enalapril Maleate Krka, tovarna
Tablets USP, 10 mg zdravil, d.d., Novo
and 20 mg. mesto, Slovenia, c/o
KRKA USA, LLC, 4216
Cravens Point Rd.,
Wilmington, NC
28409.
ANDA 075370............... Enalapril Maleate Do.
Tablets USP, 2.5 mg
and 5 mg.
[[Page 1746]]
ANDA 077895............... Ursodiol Capsules Impax Laboratories,
USP, 300 mg. LLC, 30831 Huntwood
Ave., Hayward, CA
94544.
ANDA 078810............... Oxaliplatin for Fresenius Kabi
Injection, 50 mg/ Oncology Plc., c/o
vial and 100 mg/vial. Fresenius Kabi USA,
LLC, Three Corporate
Dr., Lake Zurich, IL
60047.
ANDA 080420............... Lidocaine Lyphomed, Inc., 2045
Hydrochloride (HCl) North Cornell Ave.,
Injection USP, 1%, Melrose Park, IL
1.5%, and 2%. 60160.
ANDA 080421............... Procaine HCl Do.
Injection USP, 1%
and 2%.
ANDA 083083............... Lidocaine HCl Wyeth-Ayerst
Injection USP, 1% Laboratories, P.O.
and 2%. Box 8299,
Philadelphia, PA
19101.
ANDA 083744............... Lidocaine HCl Tera Pharmaceuticals,
Injection USP, 0.5%, Inc., 6920 Stanton
1%, 1.5%, and 2%. Ave., Buena Park, CA
90621.
ANDA 083907............... Lidocaine HCl With Do.
Epinephrine
Injection USP.
ANDA 084571............... Lidocaine HCl Knoll
Injection, 10 mg/20 Pharmaceuticals, 30
mL and 10 mg/50 mL. North Jefferson Rd.,
Whippany, NJ 07981.
ANDA 084572............... Lidocaine HCl Do.
Injection, 20 mg/20
mL and 20 mg/50 mL.
ANDA 084720............... Lidocaine HCl and Naska Pharmacal Co.,
Epinephrine Inc., Riverview Rd.,
Injection USP, 2%; P.O. Box 898,
0.01 mg/mL. Lincolnton, NC
28093.
ANDA 084732............... Lidocaine HCl and Do.
Epinephrine
Injection USP, 2%;
0.02 mg/mL.
ANDA 084947............... Alphacaine Carlisle
(lidocaine) Laboratories, Inc.,
Ointment, 5%. 404 Doughty Blvd.,
Inwood, NY 11696.
ANDA 085037............... Lidocaine HCl Akorn, Inc., P.O. Box
Injection USP, 1% 1220, Decatur, IL
and 2%. 62525.
ANDA 085677............... Cortisone Acetate Steris Laboratories,
Injectable Inc., 620 North 51st
Suspension USP, 25 Ave., Phoenix, AZ
mg/mL and 50 mg/mL. 85043.
ANDA 088051............... Thalitone Casper Pharma LLC, 2
(chlorthalidone) Tower Center Blvd.,
Tablets USP, 25 mg. Suite 1101C, East
Brunswick, NJ 08816.
ANDA 089688............... Lidocaine HCl Topical Paco Research, Corp.,
Solution USP, 4%. 1705 Oak St.,
Lakewood, NJ 08701.
ANDA 091212............... Lansoprazole Delayed- Krka, tovarna
Release Capsules zdravil, d.d., Novo
USP, 15 mg and 30 mg. mesto, c/o KRKA USA,
LLC.
ANDA 091377............... Vancomycin HCl for Xellia
Injection USP, EQ Pharmaceuticals ApS,
500 mg base/vial and c/o Xellia
EQ 1gram (g) base/ Pharmaceuticals USA,
vial. LLC, 8841 Wadford
Dr., Raleigh, NC
27616.
ANDA 206243............... Vancomycin HCl for Do.
Injection USP, EQ 5
g base/vial and EQ
10 g base/vial
(Pharmacy Bulk
Package).
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of March
7, 2019. 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 7, 2019, 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: January 16, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-01129 Filed 2-4-19; 8:45 am]
BILLING CODE 4164-01-P
