Eli Lilly and Company, et al.; Withdrawal of Approval of 3 New Drug Applications and 41 Abbreviated New Drug Applications, 22501-22502 [2014-09124]
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Federal Register / Vol. 79, No. 77 / Tuesday, April 22, 2014 / Notices
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Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–09123 Filed 4–21–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0398]
Eli Lilly and Company, et al.;
Withdrawal of Approval of 3 New Drug
Applications and 41 Abbreviated New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
SUMMARY:
22501
approval of 3 new drug applications and
41 abbreviated new drug applications
(ANDAs) from multiple applicants. The
holders of the applications notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
DATES:
Effective May 22, 2014.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
The
holders of the applications listed in
table 1 in this document have informed
FDA that these drug products are no
longer marketed and have requested that
FDA withdraw approval of the
applications under the process 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:
TABLE 1—REQUESTS TO WITHDRAW APPROVAL OF APPLICATIONS
Application No.
Drug
Applicant
NDA 050440 ......
Keflet (cephalexin) Tablets ......................................................
NDA 050614 ......
NDA 050673 ......
ANDA 075457 ....
Keftab (cephalexin hydrochloride) Tablets ..............................
Ceclor CD (cefaclor) Tablets ...................................................
Famotidine Tablets USP, 20 milligrams (mg) and 40 mg .......
ANDA 075559 ....
Butorphanol Tartrate Injection USP, 1 mg/milliliter (mL) and 2
mg/mL.
Buspirone HCl Tablets USP, 5 mg, 10 mg, and 15 mg ..........
Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN
46285.
Do.
Do.
Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O.
Box 4310, Morgantown, WV 26505–4310.
Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045.
ANDA 075572 ....
ANDA 075594 ....
ANDA 075609 ....
ANDA 075613 ....
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
075627
075730
075793
075847
075905
075943
....
....
....
....
....
....
tkelley on DSK3SPTVN1PROD with NOTICES
ANDA 075950 ....
ANDA 076018 ....
ANDA 076042 ....
ANDA 076044 ....
Pamidronate Disodium for Injection, 30 mg/vial and 90 mg/
vial.
Doxazosin Mesylate Tablets, 1 mg, 2 mg, 4 mg, and 8 mg ...
Bupropion HCl Tablets, 75 mg and 100 mg ............................
Acyclovir Injection, 50 mg/mL ..................................................
Thiotepa for Injection USP, 15 mg/vial and 30 mg/vial ...........
Famotidine Tablets USP, 20 mg and 40 mg ...........................
Oxaprozin Tablets USP, 600 mg .............................................
Famotidine Injection, 10 mg/mL ...............................................
Etodolac Extended-Release Tablets, 400 mg, 500 mg, and
600 mg.
Fluvoxamine Maleate Tablets, 50 mg and 100 mg .................
Amiodarone HCl Injection, 50 mg/mL ......................................
ANDA 076088 ....
ANDA 076193 ....
ANDA 076259 ....
Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mg ..
Potassium Chloride Extended-Release Tablets USP, 20 milliequivalents.
Amiodarone HCl Injection, 50 mg/mL ......................................
Propafenone HCl Tablets, 150 mg, 225 mg, and 300 mg ......
Milrinone Lacate in 5% Dextrose Injection ..............................
ANDA 076299 ....
Amiodarone HCl Injection, 50 mg/mL ......................................
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Nesher Pharmaceuticals (USA) LLC, 13910 St. Charles Rock
Rd., Bridgeton, MO 63044.
Teva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA
92618.
Nesher Pharmacueticals (USA) LLC.
Sandoz Inc., 2555 W. Midway Blvd., Broomfield, CO 80038–
0446.
Teva Parenteral Medicines, Inc.
Do.
Sandoz Inc.
Mylan Pharmaceuticals, Inc.
Hospira, Inc.
Sandoz Inc.
Mylan Pharmaceuticals, Inc.
Bedford Laboratories, 300 Northfield Rd., Bedford, OH
44146.
Mylan Pharmaceuticals, Inc.
Nesher Pharmaceuticals (USA) LLC.
Bedford Laboratories.
Nesher Pharmaceuticals (USA) LLC.
Baxter Healthcare Corp., 25212 W. Illinois Route 120, Round
Lake, IL 60073.
Bedford Laboratories.
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22502
Federal Register / Vol. 79, No. 77 / Tuesday, April 22, 2014 / Notices
TABLE 1—REQUESTS TO WITHDRAW APPROVAL OF APPLICATIONS—Continued
Application No.
Drug
Applicant
ANDA 076315 ....
Topiramate Tablets, 25 mg, 100 mg, and 200 mg ..................
ANDA 076372 ....
ANDA 076398 ....
Brimonidine Tartrate Ophthalmic Solution, 0.2% .....................
Tamoxifen Citrate Tablets USP, 10 mg and 20 mg ................
ANDA 076424 ....
Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mg ..
ANDA 076448 ....
ANDA 076529 ....
Topiramate Capsules, 15 mg and 25 mg ................................
Loratadine Syrup (loratadine oral solution USP), 1 mg/mL .....
ANDA 076540 ....
ANDA 076612 ....
Sertraline HCl Tablets, 25 mg, 50 mg, and 100 mg ...............
Benazepril HCl and Hydrochlorothiazide Tablets, 5 mg/6.25
mg, 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg.
Metoprolol Succinate Extended-Release Tablets, 100 mg and
200 mg.
Fluticasone Proprionate Cream, 0.05% ...................................
Prednisolone Sodium Phosphate Oral Solution USP, 5 mg/5
mL.
Ciprofloxacin Injection USP, 10 mg/mL ...................................
Ciprofloxacin Injection USP, 10 mg/mL ...................................
Lorazepam Injection USP (Preservative-Free), 2 mg/mL and
4 mg/mL.
Lorazepam Injection USP, 2 mg/mL and 4 mg/mL, 10 mL per
vial.
Amlodipine Besylate Tablets, 2.5 mg, 5 mg, and 10 mg ........
Barr Laboratories, Inc., an indirect, wholly owned subsidiary
of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd.,
Woodcliff Lake, NJ 07677.
Teva Parenteral Medicines, Inc.
Aegis Pharmaceuticals PLC, c/o GlobePharm Inc., 313 Pine
St., Suite 204, Deerfield, IL 60015.
Pliva Inc., c/o Barr Laboratories Inc., an indirect, wholly
owned subsidiary of Teva Pharmaceuticals USA, U.S.
Agent, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
Barr Laboratories, Inc.
Ranbaxy Laboratories Limited, c/o Ranbaxy Inc., U.S., 600
College Rd. East, Princeton, NJ 08540.
Mylan Pharmaceuticals, Inc.
Do.
ANDA 076640 ....
ANDA 076865 ....
ANDA 076982 ....
ANDA 076992 ....
ANDA 076993 ....
ANDA 077074 ....
ANDA 077076 ....
ANDA 077080 ....
ANDA
ANDA
ANDA
ANDA
077085
077311
085917
087423
....
....
....
....
tkelley on DSK3SPTVN1PROD with NOTICES
ANDA 087433 ....
Leflunomide Tablets, 10 mg and 20 mg ..................................
Hydromorphone HCl Tablets USP, 2 mg, 4 mg, and 8 mg ....
Acetaminophen and Codeine Phosphate Tablets, 30 mg .......
Acetaminophen and Codeine Phosphate Tablets, 300 mg/60
mg.
Acetaminophen and Codeine Phosphate Tablets, 300 mg/15
mg.
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(e)) and
under authority delegated to the
Director, Center for Drug Evaluation and
Research, by the Commissioner,
approval of the applications listed in
table 1 in this document, and all
amendments and supplements thereto,
is hereby withdrawn, effective May 22,
2014. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the FD&C Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in
table 1 that are in inventory on the date
that this notice becomes effective (see
the DATES section) 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.
Nesher Pharmaceuticals (USA) LLC.
Do.
Do.
Bedford Laboratories.
Do.
Do.
Do.
Synthon Pharmaceuticals, Inc., 9000 Development Dr., P.O.
Box 110487, Research Triangle Park, NC 27709.
Sandoz Inc.
Nesher Pharmaceuticals (USA) LLC.
Sandoz Inc.
Do.
Do.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
AGENCY:
ACTION:
Notice.
Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
[FR Doc. 2014–09124 Filed 4–21–14; 8:45 am]
DATES:
BILLING CODE 4160–01–P
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SUMMARY:
Comments on this ICR should be
received no later than May 22, 2014.
PO 00000
Frm 00034
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Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Children’s Hospitals Graduate Medical
Education Payment Program.
OMB No.: 0915–0247 Revision.
Abstract: The Children’s Hospitals
Graduate Medical Education (CHGME)
Payment Program was enacted by Public
Law 106–129 to provide federal support
for graduate medical education (GME) to
freestanding children’s hospitals. This
legislation attempts to provide support
for GME comparable to the level of
Medicare GME support received by
other, non-children’s hospitals. The
legislation requires that eligible
children’s hospitals receive payments
for both direct and indirect medical
ADDRESSES:
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]]>Agencies
[Federal Register Volume 79, Number 77 (Tuesday, April 22, 2014)]
[Notices]
[Pages 22501-22502]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09124]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0398]
Eli Lilly and Company, et al.; Withdrawal of Approval of 3 New
Drug Applications and 41 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 3 new drug applications and 41 abbreviated new drug applications
(ANDAs) from multiple applicants. The holders of the applications
notified the Agency in writing that the drug products were no longer
marketed and requested that the approval of the applications be
withdrawn.
DATES: Effective May 22, 2014.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
table 1 in this document have informed FDA that these drug products are
no longer marketed and have requested that FDA withdraw approval of the
applications under the process 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.
Table 1--Requests To Withdraw Approval of Applications
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 050440............. Keflet (cephalexin) Eli Lilly and Co.,
Tablets. Lilly Corporate
Center, Indianapolis,
IN 46285.
NDA 050614............. Keftab (cephalexin Do.
hydrochloride) Tablets.
NDA 050673............. Ceclor CD (cefaclor) Do.
Tablets.
ANDA 075457............ Famotidine Tablets USP, Mylan Pharmaceuticals,
20 milligrams (mg) and Inc., 781 Chestnut
40 mg. Ridge Rd., P.O. Box
4310, Morgantown, WV
26505-4310.
ANDA 075559............ Butorphanol Tartrate Hospira, Inc., 275
Injection USP, 1 mg/ North Field Dr., Lake
milliliter (mL) and 2 Forest, IL 60045.
mg/mL.
ANDA 075572............ Buspirone HCl Tablets Nesher Pharmaceuticals
USP, 5 mg, 10 mg, and (USA) LLC, 13910 St.
15 mg. Charles Rock Rd.,
Bridgeton, MO 63044.
ANDA 075594............ Pamidronate Disodium Teva Parenteral
for Injection, 30 mg/ Medicines, Inc., 19
vial and 90 mg/vial. Hughes, Irvine, CA
92618.
ANDA 075609............ Doxazosin Mesylate Nesher Pharmacueticals
Tablets, 1 mg, 2 mg, 4 (USA) LLC.
mg, and 8 mg.
ANDA 075613............ Bupropion HCl Tablets, Sandoz Inc., 2555 W.
75 mg and 100 mg. Midway Blvd.,
Broomfield, CO 80038-
0446.
ANDA 075627............ Acyclovir Injection, 50 Teva Parenteral
mg/mL. Medicines, Inc.
ANDA 075730............ Thiotepa for Injection Do.
USP, 15 mg/vial and 30
mg/vial.
ANDA 075793............ Famotidine Tablets USP, Sandoz Inc.
20 mg and 40 mg.
ANDA 075847............ Oxaprozin Tablets USP, Mylan Pharmaceuticals,
600 mg. Inc.
ANDA 075905............ Famotidine Injection, Hospira, Inc.
10 mg/mL.
ANDA 075943............ Etodolac Extended- Sandoz Inc.
Release Tablets, 400
mg, 500 mg, and 600 mg.
ANDA 075950............ Fluvoxamine Maleate Mylan Pharmaceuticals,
Tablets, 50 mg and 100 Inc.
mg.
ANDA 076018............ Amiodarone HCl Bedford Laboratories,
Injection, 50 mg/mL. 300 Northfield Rd.,
Bedford, OH 44146.
ANDA 076042............ Fluconazole Tablets, 50 Mylan Pharmaceuticals,
mg, 100 mg, 150 mg, Inc.
and 200 mg.
ANDA 076044............ Potassium Chloride Nesher Pharmaceuticals
Extended-Release (USA) LLC.
Tablets USP, 20
milliequivalents.
ANDA 076088............ Amiodarone HCl Bedford Laboratories.
Injection, 50 mg/mL.
ANDA 076193............ Propafenone HCl Nesher Pharmaceuticals
Tablets, 150 mg, 225 (USA) LLC.
mg, and 300 mg.
ANDA 076259............ Milrinone Lacate in 5% Baxter Healthcare
Dextrose Injection. Corp., 25212 W.
Illinois Route 120,
Round Lake, IL 60073.
ANDA 076299............ Amiodarone HCl Bedford Laboratories.
Injection, 50 mg/mL.
[[Page 22502]]
ANDA 076315............ Topiramate Tablets, 25 Barr Laboratories,
mg, 100 mg, and 200 mg. Inc., an indirect,
wholly owned
subsidiary of Teva
Pharmaceuticals USA,
400 Chestnut Ridge
Rd., Woodcliff Lake,
NJ 07677.
ANDA 076372............ Brimonidine Tartrate Teva Parenteral
Ophthalmic Solution, Medicines, Inc.
0.2%.
ANDA 076398............ Tamoxifen Citrate Aegis Pharmaceuticals
Tablets USP, 10 mg and PLC, c/o GlobePharm
20 mg. Inc., 313 Pine St.,
Suite 204, Deerfield,
IL 60015.
ANDA 076424............ Fluconazole Tablets, 50 Pliva Inc., c/o Barr
mg, 100 mg, 150 mg, Laboratories Inc., an
and 200 mg. indirect, wholly
owned subsidiary of
Teva Pharmaceuticals
USA, U.S. Agent, 400
Chestnut Ridge Rd.,
Woodcliff Lake, NJ
07677.
ANDA 076448............ Topiramate Capsules, 15 Barr Laboratories,
mg and 25 mg. Inc.
ANDA 076529............ Loratadine Syrup Ranbaxy Laboratories
(loratadine oral Limited, c/o Ranbaxy
solution USP), 1 mg/mL. Inc., U.S., 600
College Rd. East,
Princeton, NJ 08540.
ANDA 076540............ Sertraline HCl Tablets, Mylan Pharmaceuticals,
25 mg, 50 mg, and 100 Inc.
mg.
ANDA 076612............ Benazepril HCl and Do.
Hydrochlorothiazide
Tablets, 5 mg/6.25 mg,
10 mg/12.5 mg, 20 mg/
12.5 mg, and 20 mg/25
mg.
ANDA 076640............ Metoprolol Succinate Nesher Pharmaceuticals
Extended-Release (USA) LLC.
Tablets, 100 mg and
200 mg.
ANDA 076865............ Fluticasone Proprionate Do.
Cream, 0.05%.
ANDA 076982............ Prednisolone Sodium Do.
Phosphate Oral
Solution USP, 5 mg/5
mL.
ANDA 076992............ Ciprofloxacin Injection Bedford Laboratories.
USP, 10 mg/mL.
ANDA 076993............ Ciprofloxacin Injection Do.
USP, 10 mg/mL.
ANDA 077074............ Lorazepam Injection USP Do.
(Preservative-Free), 2
mg/mL and 4 mg/mL.
ANDA 077076............ Lorazepam Injection Do.
USP, 2 mg/mL and 4 mg/
mL, 10 mL per vial.
ANDA 077080............ Amlodipine Besylate Synthon
Tablets, 2.5 mg, 5 mg, Pharmaceuticals,
and 10 mg. Inc., 9000
Development Dr., P.O.
Box 110487, Research
Triangle Park, NC
27709.
ANDA 077085............ Leflunomide Tablets, 10 Sandoz Inc.
mg and 20 mg.
ANDA 077311............ Hydromorphone HCl Nesher Pharmaceuticals
Tablets USP, 2 mg, 4 (USA) LLC.
mg, and 8 mg.
ANDA 085917............ Acetaminophen and Sandoz Inc.
Codeine Phosphate
Tablets, 30 mg.
ANDA 087423............ Acetaminophen and Do.
Codeine Phosphate
Tablets, 300 mg/60 mg.
ANDA 087433............ Acetaminophen and Do.
Codeine Phosphate
Tablets, 300 mg/15 mg.
------------------------------------------------------------------------
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for Drug Evaluation and Research, by
the Commissioner, approval of the applications listed in table 1 in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective May 22, 2014. Introduction or delivery for
introduction into interstate commerce of products without approved new
drug applications violates section 301(a) and (d) of the FD&C Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in table 1 that
are in inventory on the date that this notice becomes effective (see
the DATES section) 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: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09124 Filed 4-21-14; 8:45 am]
BILLING CODE 4160-01-P
