[Federal Register Volume 89, Number 107 (Monday, June 3, 2024)]
[Notices]
[Pages 47566-47567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12065]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2462]


Pfizer, 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applications be withdrawn.

DATES: Approval is withdrawn as of July 3, 2024.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 table 1 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              Table 1--NDAs for Which Approval Is Withdrawn
------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 012427.............  Didrex (benzfetamine     Pfizer, Inc., 66
                          hydrogen chloride        Hudson Boulevard
                          (HCl)) Tablets, 25       East, New York, NY
                          milligrams (mg) and 50   10001.
                          mg.
NDA 016131.............  Clomid (clomiphene       Sanofi US Services
                          citrate) Tablets, 50     Inc., C/O Sanofi-
                          mg.                      Aventis U.S. LLC, 55
                                                   Corporate Dr.,
                                                   Bridgewater, NJ
                                                   08807.
NDA 016584.............  Navane (thiothixene      Do.
                          HCl) Capsules, 1 mg, 2
                          mg, 5 mg, 10 mg, and
                          20 mg.
NDA 019032.............  Tenex (guanfacine HCl)   Promius Pharma, LLC, C/
                          Tablets, 1 mg, 2 mg,     O Dr. Reddy's
                          and 3 mg.                Laboratories Inc.,
                                                   107 College Rd. East,
                                                   Princeton, NJ 08540.
NDA 019776.............  Concentraid              Ferring
                          (desmopressin acetate)   Pharmaceuticals Inc.,
                          Nasal Solution, 0.01%.   100 Interpace
                                                   Parkway, Parsippany,
                                                   NJ 07054.

[[Page 47567]]

 
NDA 019826.............  Theophylline and         B. Braun Medical Inc,
                          Dextrose 5% Injections   901 Marcon Blvd.,
                          in Plastic Container,    Allentown, PA 18109.
                          40 mg/100 milliliters
                          (mL), 80 mg/100 mL,
                          160 mg/100 mL, 200 mg/
                          100 mL, 320 mg/100 mL,
                          and 400 mg/100 mL.
NDA 020659.............  Norvir (ritonavir) Oral  AbbVie Inc. 1 N.
                          Solution, 80 mg/mL.      Waugekan Rd., North
                                                   Chicago, IL 60064.
NDA 020706.............  Emadine (emedastine      Novartis
                          difumarate) Ophthalmic   Pharmaceuticals Co.,
                          Solution, 0.05%.         1 Health Plaza, East
                                                   Hanover, NJ 07936-
                                                   1080
NDA 020884.............  Aggrenox (aspirin and    Boehringer Ingelheim
                          dipyridamole) Extended-  Pharmaceuticals,
                          Release Capsules, 25     Inc., 900 Ridgebury
                          mg/200 mg.               Rd, Ridgefield, CT
                                                   06877.
NDA 020928.............  Glucagon Injection, 1    Eli Lilly and Company,
                          mg/vial.                 Lilly Corporate
                                                   Center, Indianapolis,
                                                   IN 46285.
NDA 020972.............  Sustiva (efavirenz)      Bristol-Myers Squibb
                          Capsules, 50 mg, 100     Company, P.O. Box
                          mg, and 200 mg.          4000, Princeton, NJ
                                                   08543-4000.
NDA 021400.............  Levitra (vardenafil      Bayer HealthCare
                          HCI) Tablets, 2.5 mg,    Pharmaceuticals Inc.
                          5 mg, 10 mg, and 20 mg.
NDA 021449.............  Hepsera (adefovir        Gilead Sciences, Inc.,
                          dipivoxil) Tablets, 10   333 Lakeside Dr.,
                          mg.                      Foster City, CA
                                                   94404.
NDA 021623.............  Synera (lidocaine and    Galen Specialty Pharma
                          tetracaine) Patch, 70    US, LLC, 25 Fretz
                          mg/70 mg.                Rd., Souderton, PA
                                                   18694.
NDA 022331.............  Kapvay (clonidine HCl)   Concordia
                          Extended-Release         Pharmaceuticals, Inc
                          Tablets, 0.1 mg and      C/O Cardinal Health
                          0.2 mg.                  Reg Sciences, 7400
                         Jenloga (clonidine HCl)   West 110th St., Suite
                          Extended-Release         150, Overland Park,
                          Tablets, 0.1 mg and      KS 66210.
                          0.2 mg.
NDA 022343.............  Efavirenz, Lamivudine    Aurobindo Pharma
                          and Tenofovir            Limited C/O Aurobindo
                          Disoproxil Fumarate      Pharma USA, Inc., 279
                          Tablets, 600 mg/300 mg/  Princeton-Highstown
                          300 mg.                  Rd., East Windsor, NJ
                                                   08520.
NDA 022344.............  Lamivudine and           Do.
                          Tenofovir Disoproxil
                          Fumarate Tablets, 300
                          mg/300 mg.
NDA 200179.............  Staxyn (vardenafil HCl)  Bayer HealthCare
                          Orally Disintegrating    Pharmaceuticals, Inc.
                          Tablets, 10 mg.
NDA 200671.............  Durlaza (aspirin)        HESP LLC, 312
                          Extended-Release         Farmington Ave.,
                          Capsules, 162.5 mg.      Farmington, CT 06032.
NDA 202158.............  Radiogenix System        NorthStar Medical
                          (technetium Tc-99m       Radioisotopes, LLC,
                          generator) For the       1800 Gateway Blvd.,
                          Production of Sodium     Beloit, WI 53511.
                          Pertechnetate Tc 99m
                          Injection,
                          Intravenous,
                          Intravesicular, and
                          Ophthalmic Solution,
                          30-1153 millicurie/
                          Generator.
NDA 205004.............  Bortezomib Powder for    Fresenius Kabi USA,
                          Injection, 3.5 mg/vial.  LLC, 3 Corporate Dr.,
                                                   Lake Zurich, IL
                                                   60047.
NDA 205787.............  Evzio (naloxone HCl)     Kaleo, Inc., 111
                          Solution for             Virginia St., Suite
                          Injection, 0.4 mg/0.4    300, Richmond, VA
                          mL.                      23219.
NDA 209862.............  Evzio (naloxone HCl)     Do.
                          Auto-Injector for
                          Injection, 2 mg/0.4 mL.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in table 1, and all 
amendments and supplements thereto, is hereby withdrawn as of July 3, 
2024. Approval of each entire application is withdrawn, including any 
strengths and dosage forms included in the application but 
inadvertently missing from table 1. Introduction or delivery for 
introduction into interstate commerce of products listed in table 1 
without an approved new drug application 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 table 1 that are in 
inventory on July 3, 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: May 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12065 Filed 5-31-24; 8:45 am]
BILLING CODE 4164-01-P