[Federal Register Volume 79, Number 77 (Tuesday, April 22, 2014)]
[Notices]
[Pages 22501-22502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09124]
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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.
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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withdrawn.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
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Application No. Drug Applicant
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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.
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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