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VERSENATE (Edetate Calcium Disodium) Injection, 200 Milligrams per Milliliter, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 75002-75003 [2023-24120]

Download as PDF 75002 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: October 27, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–24123 Filed 10–31–23; 8:45 am] BILLING CODE 4164–01–P 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VERSENATE (Edetate Calcium Disodium) Injection, 200 Milligrams per Milliliter, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: 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, Stacy.Kane@fda.hhs.gov. 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 § 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. Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant NDA 008922 .... Injectable; Injection ........ Bausch Health US, LLC. 25 mg ................................................. Tablet; Oral .................... Nostrum Labs., Inc. NDA 012546 .... TENUATE DOSPAN ...... 75 mg ................................................. FLUOCINONIDE ............ Tablets, Extended-Release; Oral. Cream; Topical .............. Do. NDA 019117 .... Edetate Calcium Disodium. Diethylpropion Hydrochloride. Diethylpropion Hydrochloride. Fluocinonide .................. 200 Milligrams (mg)/Milliliter (mL) ..... NDA 011722 .... CALCIUM DISODIUM VERSENATE. TENUATE ...................... NDA 019796 .... NDA 020489 .... ELOCON ........................ ANDRODERM ............... Mometasone Furoate .... Testosterone .................. 0.1% ................................................... 2 mg/24 hours; 4 mg/24 hours .......... NDA 020884 .... AGGRENOX ................... Aspirin; Dipyridamole ..... 25 mg; 200 mg .................................. NDA 020903 .... REBETOL ...................... Ribavirin ......................... 200 mg ............................................... Lotion; Topical ............... Film, Extended Release; Transdermal. Capsule, Extended Release; Oral. Capsule; Oral ................. NDA 020907 .... ACTIVELLA ................... 0.5 mg; 0.1 mg .................................. Tablet; Oral .................... NDA 020949 .... ACCUNEB ..................... Estradiol; Norethindrone Acetate. Albuterol Sulfate ............ Boehringer Ingelheim Pharms., Inc. Merck Sharp and Dohme Corp. Amneal Pharms., LLC. Solution; Inhalation ........ Mylan Specialty LP. NDA 021022 .... PENLAC ........................ Ciclopirox ....................... Equivalent to (EQ) 0.021% Base; EQ 0.042% Base. 8% ...................................................... Solution; Topical ............ NDA 021449 .... NDA 022052 .... HEPSERA ...................... ZYFLO CR ..................... Adefovir Dipivoxil ........... Zileuton .......................... 10 mg ................................................. 600 mg ............................................... Valeant International Bermuda. Gilead Sciences, Inc. Chiesi USA, Inc. NDA 022511 .... VIMOVO ........................ NDA 022569 .... LAZANDA ...................... Esomeprazole Magnesium; Naproxen. Fentanyl Citrate ............. NDA 202788 .... SUBSYS ........................ Fentanyl ......................... NDA 213645 .... DAPZURA RT ................ Daptomycin .................... EQ 20 mg Base; 375 mg; EQ 20 mg Base; 500 mg. EQ 0.1mg Base; EQ 0.3 mg Base; EQ 0.4 mg Base. 0.1 mg; 0.2 mg; 0.4 mg; 0.6 mg; 0.8 mg; 1.2 mg; 1.6 mg. 500 mg/Vial ........................................ FDA has reviewed its records and, under § 314.161, has determined that the drug products listed were not VerDate Sep<11>2014 19:48 Oct 31, 2023 Jkt 262001 0.05% ................................................. withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 Tablet; Oral .................... Tablet, Extended Release; Oral. Tablet, Delayed Release; Oral. Spray, Metered; Nasal ... Taro Pharms. U.S.A., Inc. Organon, LLC. AbbVie Inc. Horizon Medicines LLC. BTcP Pharma, LLC. Spray; Sublingual .......... Do. Powder; Intravenous ...... Baxter Healthcare Corp. products in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product E:\FR\FM\01NON1.SGM 01NON1 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–E–3178] Determination of Regulatory Review Period for Purposes of Patent Extension; Omegaven AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Omegaven and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. DATES: Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by January 2, 2024. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 29, 2024. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 19:48 Oct 31, 2023 Jkt 262001 considered. Electronic comments must be submitted on or before January 2, 2024. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 2, 2024.Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–E–3178 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; OMEGAVEN.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 75003 Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human E:\FR\FM\01NON1.SGM 01NON1

Agencies

[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.

-----------------------------------------------------------------------

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, 
[email protected].

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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