[Federal Register Volume 88, Number 210 (Wednesday, November 1, 2023)]
[Notices]
[Pages 75002-75003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24120]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4319]


Determination That CALCIUM DISODIUM VERSENATE (Edetate Calcium 
Disodium) Injection, 200 Milligrams per Milliliter, and Other Drug 
Products Were Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that the drug products listed in this document were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination means that FDA will not begin procedures to withdraw 
approval of abbreviated new drug applications (ANDAs) that refer to 
these drug products, and it will allow FDA to continue to approve ANDAs 
that refer to the products as long as they meet relevant legal and 
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, 
<a href="/cdn-cgi/l/email-protection#edbe998c8e94c3a68c8388ad8b898cc385859ec38a829b"><span class="__cf_email__" data-cfemail="5d0e293c3e2473163c33381d3b393c7335352e733a322b">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of 
an ANDA to market a generic version of a previously approved drug 
product. To obtain approval, the ANDA applicant must show, among other 
things, that the generic drug product: (1) has the same active 
ingredient(s), dosage form, route of administration, strength, 
conditions of use, and (with certain exceptions) labeling as the listed 
drug, which is a version of the drug that was previously approved and 
(2) is bioequivalent to the listed drug. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of 
all approved drugs. FDA publishes this list as part of the ``Approved 
Drug Products With Therapeutic Equivalence Evaluations,'' which is 
generally known as the ``Orange Book.'' Under FDA regulations, a drug 
is removed from the list if the Agency withdraws or suspends approval 
of the drug's NDA or ANDA for reasons of safety or effectiveness or if 
FDA determines that the listed drug was withdrawn from sale for reasons 
of safety or effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must 
determine whether a listed drug was withdrawn from sale for reasons of 
safety or effectiveness: (1) before an ANDA that refers to that listed 
drug may be approved, (2) whenever a listed drug is voluntarily 
withdrawn from sale and ANDAs that refer to the listed drug have been 
approved, and (3) when a person petitions for such a determination 
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if 
FDA determines that a listed drug was withdrawn from sale for safety or 
effectiveness reasons, the Agency will initiate proceedings that could 
result in the withdrawal of approval of the ANDAs that refer to the 
listed drug.
    FDA has become aware that the drug products listed in the table are 
no longer being marketed.

----------------------------------------------------------------------------------------------------------------
                                             Active
  Application No.       Drug name        ingredient(s)       Strength(s)     Dosage form/route      Applicant
----------------------------------------------------------------------------------------------------------------
NDA 008922........  CALCIUM DISODIUM   Edetate Calcium    200 Milligrams     Injectable;        Bausch Health
                     VERSENATE.         Disodium.          (mg)/Milliliter    Injection.         US, LLC.
                                                           (mL).
NDA 011722........  TENUATE..........  Diethylpropion     25 mg............  Tablet; Oral.....  Nostrum Labs.,
                                        Hydrochloride.                                           Inc.
NDA 012546........  TENUATE DOSPAN...  Diethylpropion     75 mg............  Tablets, Extended- Do.
                                        Hydrochloride.                        Release; Oral.
NDA 019117........  FLUOCINONIDE.....  Fluocinonide.....  0.05%............  Cream; Topical...  Taro Pharms.
                                                                                                 U.S.A., Inc.
NDA 019796........  ELOCON...........  Mometasone         0.1%.............  Lotion; Topical..  Organon, LLC.
                                        Furoate.
NDA 020489........  ANDRODERM........  Testosterone.....  2 mg/24 hours; 4   Film, Extended     AbbVie Inc.
                                                           mg/24 hours.       Release;
                                                                              Transdermal.
NDA 020884........  AGGRENOX.........  Aspirin;           25 mg; 200 mg....  Capsule, Extended  Boehringer
                                        Dipyridamole.                         Release; Oral.     Ingelheim
                                                                                                 Pharms., Inc.
NDA 020903........  REBETOL..........  Ribavirin........  200 mg...........  Capsule; Oral....  Merck Sharp and
                                                                                                 Dohme Corp.
NDA 020907........  ACTIVELLA........  Estradiol;         0.5 mg; 0.1 mg...  Tablet; Oral.....  Amneal Pharms.,
                                        Norethindrone                                            LLC.
                                        Acetate.
NDA 020949........  ACCUNEB..........  Albuterol Sulfate  Equivalent to      Solution;          Mylan Specialty
                                                           (EQ) 0.021%        Inhalation.        LP.
                                                           Base; EQ 0.042%
                                                           Base.
NDA 021022........  PENLAC...........  Ciclopirox.......  8%...............  Solution; Topical  Valeant
                                                                                                 International
                                                                                                 Bermuda.
NDA 021449........  HEPSERA..........  Adefovir           10 mg............  Tablet; Oral.....  Gilead Sciences,
                                        Dipivoxil.                                               Inc.
NDA 022052........  ZYFLO CR.........  Zileuton.........  600 mg...........  Tablet, Extended   Chiesi USA, Inc.
                                                                              Release; Oral.
NDA 022511........  VIMOVO...........  Esomeprazole       EQ 20 mg Base;     Tablet, Delayed    Horizon
                                        Magnesium;         375 mg; EQ 20 mg   Release; Oral.     Medicines LLC.
                                        Naproxen.          Base; 500 mg.
NDA 022569........  LAZANDA..........  Fentanyl Citrate.  EQ 0.1mg Base; EQ  Spray, Metered;    BTcP Pharma,
                                                           0.3 mg Base; EQ    Nasal.             LLC.
                                                           0.4 mg Base.
NDA 202788........  SUBSYS...........  Fentanyl.........  0.1 mg; 0.2 mg;    Spray; Sublingual  Do.
                                                           0.4 mg; 0.6 mg;
                                                           0.8 mg; 1.2 mg;
                                                           1.6 mg.
NDA 213645........  DAPZURA RT.......  Daptomycin.......  500 mg/Vial......  Powder;            Baxter
                                                                              Intravenous.       Healthcare
                                                                                                 Corp.
----------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug products listed were not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the Agency will 
continue to list the drug products in the ``Discontinued Drug Product 
List'' section of the Orange Book. The ``Discontinued Drug Product

[[Page 75003]]

List'' identifies, among other items, drug products that have been 
discontinued from marketing for reasons other than safety or 
effectiveness.
    Approved ANDAs that refer to the drug products listed are 
unaffected by the discontinued marketing of the products subject to 
these applications. Additional ANDAs that refer to these products may 
also be approved by the Agency if they comply with relevant legal and 
regulatory requirements. If FDA determines that labeling for these drug 
products should be revised to meet current standards, the Agency will 
advise ANDA applicants to submit such labeling.

    Dated: October 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24120 Filed 10-31-23; 8:45 am]
BILLING CODE 4164-01-P


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