[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Notices]
[Pages 47309-47310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19348]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3658]
Eli Lilly and Co., et al.; Withdrawal of Approval of 25 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 25 new drug applications (NDAs) 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applications be withdrawn.
DATES: Approval is withdrawn as of October 9, 2019.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.
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 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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NDA 007529................. Quinidine Gluconate Eli Lilly and Co.,
Injection, 80 Lilly Corporate
milligrams (mg)/ Center,
milliliters (mL). Indianapolis, IN
46285.
NDA 016096................. Mintezol Merck Sharp and
(thiabendazole) Dohme Corp., a
Chewable Tablet, 500 subsidiary of Merck
mg. and Co., Inc., 1
Merck Dr., P.O. Box
100, Whitehouse
Station, NJ 08889-
0100.
NDA 016097................. Mintezol Do.
(thiabendazole)
Suspension 500 mg/5
mL.
NDA 017439................. Hydroxyprogesterone Allergan Sales,
Caproate Injection, LLC., 5 Giralda
125 mg/mL and 250 mg/ Farms, Madison, NJ
mL. 07940.
NDA 017831................. Didronel (etidronate Allergan
disodium) Tablet, Pharmaceuticals
200 mg and 400 mg. International
Limited, c/o
Allergan Sales,
LLC., 2525 Dupont
Dr., Irvine, CA
92612.
NDA 019081................. Estraderm (estradiol Novartis
transdermal system), Pharmaceuticals
0.05 mg/24 hour (h) Corp., 1 Health
and 0.1 mg/24 h. Plaza, East
Hanover, NJ 07936-
1080.
NDA 019596................. Magnevist Bayer HealthCare
(gadopentetate Pharmaceuticals,
dimeglumine) Inc., 100 Bayer
Injection, 469.01 mg/ Blvd., P.O. Box
mL. 915, Whippany, NJ
07981-0915.
NDA 020071................. Desogen (desogestrel Organon USA, Inc., a
and ethinyl subsidiary of Merck
estradiol) Tablets, and Co., Inc., 2000
0.15 mg/0.03 mg. Galloping Hill Rd.,
Kenilworth, NJ
07033.
NDA 020120................. AllerNaze Lupin Atlantis
(triamcinolone Holdings, S.A., c/o
acetonide) Nasal Lupin
Spray, 0.05 mg/spray. Pharmaceuticals,
Inc., 111 South
Calvert St.,
Harborplace Tower,
24th Floor,
Baltimore, MD
21202.
NDA 020628................. Invirase (saquinavir Hoffmann-La Roche,
mesylate) Capsules, Inc., 1 DNA Way,
equivalent to (EQ) South San
200 mg base. Francisco, CA,
94080-4990.
[[Page 47310]]
NDA 020937................. Optimark Liebel-Flarsheim
(gadoversetamide) Co., LLC., 1034
Injection, 330.9 mg/ South Brentwood
mL. Blvd., Suite 800,
Richmond Heights,
MO 63117.
NDA 020947................. Pennsaid (diclofenac Nuvo
sodium) Topical Pharmaceuticals,
Solution, 1.5% Inc., c/o Dwayne
weight by weight (w/ R.J. Moore, 41
w). Campus Dr., Suite
202, New
Gloucester, ME
04260.
NDA 020975................. Optimark Liebel-Flarsheim
(gadoversetamide) Co., LLC.
Injection, 330.9 mg/
mL.
NDA 020976................. Optimark Do.
(gadoversetamide)
Injection, 330.9 mg/
mL.
NDA 021037................. Magnevist Bayer HealthCare
(gadopentetate Pharmaceuticals,
dimeglumine) Inc.
Injection, 469.01 mg/
mL.
NDA 021105................. Sulfamethoxazole and Able Laboratories,
Trimethoprim Inc., 1 Able Dr.,
Tablets, 800 mg/160 Cranbury, NJ 08512.
mg; and
Phenazopyridine HCL
Tablets, 200 mg.
NDA 021144................. Ketek (telithromycin) Sanofi-Aventis U.S.,
Tablets, 300 mg and LLC., 55 Corporate
400 mg. Dr., Bridgewater,
NJ 08807.
NDA 021178................. Glucovance (glyburide Bristol-Myers Squibb
and metformin Co., P.O. Box 4000,
hydrocholoride Mail Stop: D.2341,
(HCl)) Tablets, 1.25 Princeton, NJ 08543-
mg/250 mg, 2.5 mg/ 4000.
500 mg, 5 mg/500 mg.
NDA 021235................. Prozac Weekly Eli Lilly and Co.
(fluoxetine delayed-
release capsules) 90
mg.
NDA 021490................. Femcon Fe (ethinyl Allergan
estradiol and Pharmaceuticals
norethindrone International
tablets, 0.035 mg/ Limited, c/o
0.4 mg; and ferrous Allergan Sales,
fumarate tablets, 75 LLC., 5 Giralda
mg). Farms, Madison, NJ
07940.
NDA 022011................. Tyzeka (telbivudine) Novartis
Tablets, 600 mg. Pharmaceuticals
Corp.
NDA 022154................. Tyzeka (telbivudine) Do.
Solution, 100 mg/5
mL.
NDA 022328................. Intermezzo (zolpidem Purdue
tartrate) Sublingual Pharmaceutical
Tablets, 1.75 mg and Products L.P., 1
3.5 mg. Stamford Forum,
Stamford, CT 06901-
3431.
NDA 050456................. Statrol (neomycin Alcon Laboratories,
sulfate and Inc., 6201 South
polymyxin B sulfate Freeway, Mail Stop:
ophthalmic solution, TC-45, Fort Worth,
USP) EQ 3.5 mg base/ TX 76134-2099.
mL; equal to 16,250
units polymyxin B/mL.
NDA 204553................. ColPrep Kit Gator
(magnesium sulfate, Pharmaceuticals,
potassium sulfate, Inc., 194 Inlet
and sodium sulfate) Dr., Saint
for Oral Solution, Augustine, FL
1.6 grams (g)/3.13 g/ 32080.
17.5 g.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
October 9, 2019. 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 October 9, 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: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19348 Filed 9-6-19; 8:45 am]
BILLING CODE 4164-01-P