[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28950-28951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10367]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1117]
Janssen Pharmaceuticals, Inc., et al.; Withdrawal of Approval of
16 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 16 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applications be withdrawn.
DATES: Approval is withdrawn as of June 15, 2020.
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 011529............... Parafon Forte DSC Janssen
(chlorzoxazone), Pharmaceuticals,
Caplets, 500 Inc., 1000 Route 202
milligrams (mg). South, P.O. Box 300,
Raritan, NJ 08869.
NDA 018029............... Ritalin-SR Novartis
(methylphenidate Pharmaceuticals
hydrochloride (HCl)) Corp., 1 Health
Extended-Release Plaza, East Hanover,
Tablets, 20 mg. NJ 07936.
NDA 018082............... Depakene (valproic AbbVie Inc., 1 North
acid) Oral Solution, Waukegan Rd., North
250 mg/5 milliliter Chicago, IL 60064.
(mL).
NDA 019579............... Terazol 7 Janssen
(terconazole) Vaginal Pharmaceuticals,
Cream, 0.4%. Inc., 1125 Trenton-
Harbourton Rd.,
Titusville, NJ
08560.
NDA 020119............... Vumon (teniposide) HQ Specialty Pharma,
Injection, 10 mg/mL. 120 Route 17 North,
Paramus, NJ 07652.
NDA 020388............... Navelbine (vinorelbine Pierre Fabre
tartrate) Injection, Medicament c/o
Equivalent to (EQ) 10 Pierre Fabre
mg/mL base. Pharmaceuticals,
Inc., 8 Campus Dr.,
Suite 202,
Parsippany, NJ
07054.
NDA 020741............... Prandin (repaglinide) Gemini Laboratories,
Tablets, 0.5 mg, 1.0 LLC, 400 Crossing
mg, and 2.0 mg. Blvd., 5th Floor,
Bridgewater, NJ
08807.
NDA 020920............... Natrecor (nesiritide) Scios, LLC, 1125
Injection, 1.5 mg/ Trenton-Harbourton
vial. Rd., Titusville, NJ
08560.
NDA 021001............... Axert (almotriptan Janssen
malate) Tablets, EQ Pharmaceuticals,
6.25 mg base and EQ Inc.
12.5 mg base.
NDA 021203............... Tricor (fenofibrate) AbbVie Inc.
Tablets, 54 mg and
160 mg.
NDA 021543............... Striant (testosterone Auxilium
buccal system) Pharmaceuticals,
Extended-Release Inc., 1400 Atwater
Tablets, 30 mg. Dr., Malvern, PA
19355.
NDA 021604............... Children's ElixSure IB Moberg Pharma North
(ibuprofen) Oral America LLC, 7 East
Suspension, 100mg/5 Frederick Place,
mL. Suite 100, Cedar
Knolls, NJ 07927.
[[Page 28951]]
NDA 021611............... Opana (oxymorphone Endo Pharmaceuticals,
HCl) Tablets, 5mg and Inc., 1400 Atwater
10mg. Dr., Malvern, PA
19355.
NDA 022321............... Embeda (morphine Alpharma
sulfate and Pharmaceuticals,
naltrexone HCl) LLC, 235 East 42nd
Extended-Release St., New York, NY
Capsules, 20 mg/0.8 10017.
mg, 30 mg/1.2 mg, 50
mg/2 mg, 60 mg/2.4
mg, 80 mg/3.2 mg, and
100 mg/4 mg.
NDA 022510............... Abstral (fentanyl) Sentynl Therapeutics,
Sublingual Inc., 420 Stevens
Tablets,100 Ave., Suite 200,
micrograms (mcg), 200 Solana Beach, CA
mcg, 300 mcg, 400 92075.
mcg, 600 mcg, and 800
mcg.
NDA 050641............... Monodox (doxycycline Aqua Pharmaceuticals,
monohydrate) LLC, 707 Eagleview
Capsules, EQ 50mg Blvd., Suite 200,
base, EQ 75mg base, Exton, PA 19341.
and EQ 100mg base.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of June
15, 2020. 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 June 15, 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: May 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10367 Filed 5-13-20; 8:45 am]
BILLING CODE 4164-01-P