[Federal Register Volume 89, Number 79 (Tuesday, April 23, 2024)]
[Notices]
[Pages 30379-30380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08657]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1786]


PAI Holdings, LLC DBA Pharmaceutical Associates, Inc., et al.; 
Withdrawal of Approval of 23 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 23 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applications be withdrawn.

DATES: Approval is withdrawn as of May 23, 2024.

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, [email protected].

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.

[[Page 30380]]



------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 007959.............  Tensilon (edrophonium    PAI Holdings, LLC dba
                          chloride) Injection,     Pharmaceutical
                          10 milligrams (mg)/      Associates, Inc.,
                          milliliter (mL).         1700 Perimeter Rd.,
                         Tensilon Preservative     Greenville, SC 29605.
                          Free (edrophonium
                          chloride) Injection,
                          10 mg/mL.
NDA 009900.............  Cortef (hydrocortisone   Pharmacia and Upjohn
                          cypionate) Oral          Co., 66 Hudson Blvd.
                          Suspension, Equivalent   East, New York, NY
                          to (EQ) 10 mg base/5     10001.
                          mL.
NDA 015923.............  Haldol (haloperidol      Janssen
                          lactate) Injection, EQ   Pharmaceuticals,
                          5 mg base/mL.            Inc., 1000 U.S. Route
                                                   202, Raritan, NJ
                                                   08869.
NDA 017090.............  Tofranil-PM (imipramine  SpecGx LLC, 385
                          pamoate) Capsules, EQ    Marshall Ave.,
                          75 mg hydrochloride      Webster Groves, MO
                          (HCl), EQ 100 mg HCl,    63119.
                          EQ 125 mg HCl, and EQ
                          150 mg HCl.
NDA 018309.............  Topicort LP              Taro Pharmaceuticals
                          (desoximetasone)         U.S.A., Inc., 3
                          Emollient Cream, 0.05%.  Skyline Dr.,
                                                   Hawthorne, NY 10532.
NDA 018401.............  Buprenex (buprenorphine  Indivior Inc., 10710
                          HCl) Injection, EQ 0.3   Midlothian Turnpike,
                          mg base/mL.              Suite 125, North
                                                   Chesterfield, VA
                                                   23235.
NDA 019201.............  Voltaren (diclofenac     Novartis
                          sodium) Delayed-         Pharmaceuticals
                          Release Tablets, 25      Corp., 1 Health
                          mg, 50 mg, and 75 mg.    Plaza, East Hanover,
                                                   NJ 07936.
NDA 019425.............  Trandate (labetalol      Sebela Ireland
                          HCl) Injection, 5 mg/    Limited, c/o Sebela
                          mL.                      Pharmaceuticals Inc.,
                                                   645 Hembree Pkwy.,
                                                   Suite 1, Roswell, GA
                                                   30076.
NDA 020142.............  Cataflam (diclofenac     Novartis
                          potassium) Tablets, 25   Pharmaceuticals Corp.
                          mg and 50 mg.
NDA 020254.............  Voltaren XR (diclofenac  Do.
                          sodium) Extended-
                          Release Tablets, 100
                          mg.
NDA 020631.............  Morphine Sulfate         SpecGx LLC.
                          Injection, 1 mg/mL and
                          2 mg/mL.
NDA 020768.............  Zomig (zolmitriptan)     iPR Pharmaceuticals,
                          Tablets, 2.5 mg and 5    Inc., c/o AstraZeneca
                          mg.                      Pharmaceuticals LP,
                                                   1800 Concord Pike,
                                                   Wilmington, DE 19803.
NDA 020897.............  Ditropan XL (oxybutynin  Janssen
                          chloride) Extended-      Pharmaceuticals, Inc.
                          Release Tablets, 5 mg,
                          10 mg, and 15 mg.
NDA 020945.............  Norvir (ritonavir)       AbbVie Inc., 1 N.
                          Capsules, 100 mg.        Waukegan Rd., North
                                                   Chicago, IL 60064.
NDA 021226.............  Kaletra (lopinavir/      Do.
                          ritonavir) Capsules,
                          133.3 mg/33.3 mg.
NDA 021231.............  Zomig-ZMT                iPR Pharmaceuticals,
                          (zolmitriptan) Orally    Inc., c/o AstraZeneca
                          Disintegrating           Pharmaceuticals LP.
                          Tablets, 2.5 mg and 5
                          mg.
NDA 021360.............  Sustiva (efavirenz)      Bristol-Myers Squibb
                          Tablets, 300 mg and      Company, P.O. Box
                          600 mg.                  4000, Princeton, NJ
                                                   08543-4000.
NDA 022484.............  Onmel (itraconazole)     Sebela Ireland
                          Tablets, 200 mg.         Limited, c/o Sebela
                                                   Pharmaceuticals Inc.
NDA 050679.............  Maxipime (cefepime HCl)  Hospira Inc, 275 North
                          for Injection, EQ 500    Field Dr., Bldg. H1-
                          mg base/vial, EQ 1       3S, Lake Forest, IL
                          gram base/vial, and EQ   60045.
                          2 gram base/vial.
NDA 203696.............  Lupaneta Pack            AbbVie Endocrinology
                          (leuprolide acetate      Inc., 1 N Waukegan
                          injection and            Rd., North Chicago,
                          norethindrone acetate    IL 60064.
                          Tablets), 3.75 mg/
                          vial;5 mg and 11.25 mg/
                          vial;5 mg.
NDA 206302.............  Byvalson (nebivolol HCl/ AbbVie Inc.
                          valsartan) Tablets, EQ
                          5 mg base/80 mg.
NDA 208042.............  Cassipa (buprenorphine   Teva Pharmaceuticals
                          HCl/naloxone HCl)        USA, Inc., 577
                          Sublingual Film, EQ 16   Chipeta Way, Salt
                          mg base/EQ 4 mg base.    Lake City, UT 84108.
NDA 208437.............  Lonhala Magnair Kit      Sumitomo Pharma
                          (glycopyrrolate)         America, Inc., 84
                          Inhalation Solution,     Waterford Dr.,
                          25 microgram/mL.         Marlborough, MA
                                                   01752.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of May 
23, 2024. Approval of each entire application is withdrawn, including 
any strengths and dosage forms included in the application but 
inadvertently missing from the table. Introduction or delivery for 
introduction into interstate commerce of products listed in the table 
without an approved NDA violates sections 505(a) and 301(d) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). 
Drug products that are listed in the table that are in inventory on May 
23, 2024, 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 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08657 Filed 4-22-24; 8:45 am]
BILLING CODE 4164-01-P