[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applications be withdrawn.

DATES: Approval is withdrawn as of June 15, 2020.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.

------------------------------------------------------------------------
     Application No.                Drug                 Applicant
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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


