Determination That VOSOL (Acetic Acid, Glacial) 2% Otic Solution/Drops; and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 19721-19722 [2025-08207]

Download as PDF 19721 Federal Register / Vol. 90, No. 89 / Friday, May 9, 2025 / Notices location of floodplains relative to the project area, GSA has assumed that the project area is located within a 1percent-annual-chance or 0.2-percentannual-chance floodplain for purposes of complying with Executive Order 11988 and the GSA Floodplain Management Desk Guide, and until such time that a floodplain hazard study can be conducted. In addition, based on a wetland delineation conducted for the project, approximately 3.3 acres of wetlands occur within the project area. GSA prepared a Floodplain and Wetlands Assessment and Statement of Findings addressing potential impacts on floodplains and wetlands, which is included in the Final EIS. Final design of the Grand Portage LPOE would incorporate standard measures, including those specified in GSA Interim Core Building Standards as well as by the authority having jurisdiction, to reduce or manage stormwater flows as well as any potential impacts to the floodplain if present. GSA would coordinate as necessary with the Grand Portage Band to obtain appropriate permits and approvals related to wetlands disturbance under the Clean Water Act. Further, GSA would consider options to minimize, avoid, or mitigate potential impacts, as required by the U.S. Army Corps of Engineers and/or the Grand Portage Band. Russell Riberto, Regional Commissioner, Great Lakes Region 5, U.S. General Services Administration. [FR Doc. 2025–07964 Filed 5–8–25; 8:45 am] BILLING CODE 6820–CF–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2025–N–0679] Determination That VOSOL (Acetic Acid, Glacial) 2% Otic Solution/Drops; and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 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. SUMMARY: 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. lotter on DSK11XQN23PROD with NOTICES1 TABLE 1—DRUG PRODUCTS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS Application No. Drug name Active ingredient(s) Dosage form/route Strength(s) NDA 012179 ............ NDA 012836 ............ VOSOL ............................. PERSANTINE .................. Acetic Acid, Glacial .......... Dipyridamole .................... Solution/Drops; Otic ......... Tablet; Oral ...................... Hikma. Boehringer Ingelheim. NDA 013790 ............ NDA 016758 ............ CORDRAN ....................... NAVANE .......................... Flurandrenolide ................ Thiothixene Hydrochloride Lotion; Topical .................. Concentrate; Oral ............. Almirall. Pfizer. NDA 017604 ............ NALFON ........................... Fenoprofen Calcium ......... Capsule; Oral ................... Key Therapeutics. NDA 019737 ............ METROGEL ..................... Metronidazole ................... 2% .................................... 25 Milligrams (mg); 50 mg; 75 mg. 0.05% ............................... Equivalent to (EQ) 5 mg Base/Milliliters (mL). EQ 200 mg Base; EQ 400 mg Base. 0.75% ............................... Gel; Topical ...................... NDA 019909 ............ NDA 019922 ............ NDA 020212 ............ ZOVIRAX ......................... CORLOPAM ..................... ZINECARD ....................... ZOFRAN .......................... 200 mg/5 mL .................... EQ 10 mg Base/mL ......... EQ 250 mg Base/Vial; EQ 500 mg Base/Vial. EQ 4 mg Base/5 mL ........ Suspension; Oral ............. Injectable; Injection .......... Injectable; Injection .......... NDA 020605 ............ Solution; Oral ................... Sandoz. NDA 020636 ............ NDA 020645 ............ VIRAMUNE ...................... AMMONUL ....................... Boehringer Ingelheim. Bausch Health. LUXIQ .............................. 200 mg ............................. 10%; 10% (5 Grams (g)/ 50 mL; 5 g/50 mL). 0.12% ............................... Tablet; Oral ...................... Solution; Intravenous ....... NDA 020934 ............ Acyclovir ........................... Fenoldopam Mesylate ...... Dexrazoxane Hydrochloride. Ondansetron Hydrochloride. Nevirapine ........................ Sodium Benzoate; Sodium Phenylacetate. Betamethasone Valerate Galderma Laboratories LP. Norvium Bioscience. Hospira. Pfizer. Aerosol, Foam; Topical .... Norvium Bioscience. VerDate Sep<11>2014 17:11 May 08, 2025 Jkt 265001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\09MYN1.SGM 09MYN1 Applicant 19722 Federal Register / Vol. 90, No. 89 / Friday, May 9, 2025 / Notices TABLE 1—DRUG PRODUCTS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS—Continued Application No. Drug name Active ingredient(s) Dosage form/route Strength(s) Applicant NDA 021071 ............ AVANDIA ......................... Rosiglitazone Maleate ...... Tablet; Oral ...................... NDA 021160 ............ NDA 021360 ............ NDA 021493 ............ PHOSLO GELCAPS ........ SUSTIVA .......................... ZYMAR ............................. Calcium Acetate ............... Efavirenz .......................... Gatifloxacin ...................... EQ 2 mg Base; EQ 4 mg Base. 667 mg ............................. 600 mg ............................. 0.3% ................................. Woodward Pharma Services LLC. Fresenius Medical Care. Bristol Myers Squibb. Allergan. NDA 021656 ............ NDA 021759 ............ TRICOR ........................... ELOXATIN ....................... Fenofibrate ....................... Oxaliplatin ........................ NDA 021779 ............ VENTAVIS ....................... Iloprost ............................. NDA 021849 ............ ZEGERID ......................... NDA 022428 ............ MOXEZA .......................... NDA 050006 ............ NDA 050541 ............ VIBRAMYCIN ................... TOBREX .......................... Omeprazole; Sodium Bicarbonate. Moxifloxacin Hydrochloride. Doxycycline ...................... Tobramycin ...................... NDA 050808 ............ SOLODYN ........................ Minocycline Hydrochloride NDA 207987 ............ NDA 208183 ............ ABLYSINOL ..................... ULTRAVATE .................... Alcohol ............................. Halobetasol Propionate .... FDA has reviewed its records and, under § 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 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: May 6, 2025. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025–08207 Filed 5–8–25; 8:45 am] lotter on DSK11XQN23PROD with NOTICES1 BILLING CODE 4164–01–P VerDate Sep<11>2014 17:11 May 08, 2025 Jkt 265001 48 mg; 145 mg ................. 50 mg/10 mL (5 mg/mL); 100 mg/20 mL (5 mg/ mL). 10 Micrograms (mcg)/mL (10 mcg/mL); 20 mcg/ mL (20 mcg/mL). 20 mg, 1.1 g; 40 mg, 1.1 g. EQ 0.5% Base ................. EQ 25 mg Base/5 mL ...... 0.3% ................................. 55 mg; 65 mg; 80 mg; 105 mg; 115 mg. 99% (1 mL) ...................... 0.05% ............................... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2025–N–1090] Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of availability; request for comments. ACTION: The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ‘‘Product Quality Information Request Communications Assessment: Final Report.’’ This report fulfills a commitment under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA) to assess communication between FDA and applicants through product quality information requests during application review and to identify best practices and areas of improvement. The assessment of FDA and applicants in communicating through product quality information requests was conducted by an independent contractor, as described in the document entitled ‘‘PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027.’’ As part of FDA performance commitments described in this document, FDA is publishing the final assessment report and soliciting public comments. SUMMARY: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Capsule; Oral ................... Tablet; Oral ...................... Solution/Drops; Ophthalmic. Tablet; Oral ...................... Injectable; Intravenous ..... Abbvie. Sanofi Aventis US. Solution; Inhalation .......... Actelion. Capsule; Oral ................... Salix. Solution/Drops; Ophthalmic. For Suspension; Oral ....... Solution/Drops; Ophthalmic. Tablet, Extended Release; Oral. Solution; Intra-Arterial ...... Lotion; Topical .................. Harrow Eye. Pfizer. Novartis. Bausch. BPI Labs, LLC. Lacer Pharmaceuticals. Submit either electronic or written comments on the final report by July 31, 2025. ADDRESSES: You may submit either electronic or written comments as follows: DATES: 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 E:\FR\FM\09MYN1.SGM 09MYN1

Agencies

[Federal Register Volume 90, Number 89 (Friday, May 9, 2025)]
[Notices]
[Pages 19721-19722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-08207]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-N-0679]


Determination That VOSOL (Acetic Acid, Glacial) 2% Otic Solution/
Drops; 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.

              Table 1--Drug Products Not Withdrawn From Sale for Reasons of Safety or Effectiveness
----------------------------------------------------------------------------------------------------------------
                                                Active         Dosage form/
    Application No.          Drug name       ingredient(s)         route          Strength(s)       Applicant
----------------------------------------------------------------------------------------------------------------
NDA 012179.............  VOSOL...........  Acetic Acid,      2%..............  Solution/Drops;   Hikma.
                                            Glacial.                            Otic.
NDA 012836.............  PERSANTINE......  Dipyridamole....  25 Milligrams     Tablet; Oral....  Boehringer
                                                              (mg); 50 mg; 75                     Ingelheim.
                                                              mg.
NDA 013790.............  CORDRAN.........  Flurandrenolide.  0.05%...........  Lotion; Topical.  Almirall.
NDA 016758.............  NAVANE..........  Thiothixene       Equivalent to     Concentrate;      Pfizer.
                                            Hydrochloride.    (EQ) 5 mg Base/   Oral.
                                                              Milliliters
                                                              (mL).
NDA 017604.............  NALFON..........  Fenoprofen        EQ 200 mg Base;   Capsule; Oral...  Key
                                            Calcium.          EQ 400 mg Base.                     Therapeutics.
NDA 019737.............  METROGEL........  Metronidazole...  0.75%...........  Gel; Topical....  Galderma
                                                                                                  Laboratories
                                                                                                  LP.
NDA 019909.............  ZOVIRAX.........  Acyclovir.......  200 mg/5 mL.....  Suspension; Oral  Norvium
                                                                                                  Bioscience.
NDA 019922.............  CORLOPAM........  Fenoldopam        EQ 10 mg Base/mL  Injectable;       Hospira.
                                            Mesylate.                           Injection.
NDA 020212.............  ZINECARD........  Dexrazoxane       EQ 250 mg Base/   Injectable;       Pfizer.
                                            Hydrochloride.    Vial; EQ 500 mg   Injection.
                                                              Base/Vial.
NDA 020605.............  ZOFRAN..........  Ondansetron       EQ 4 mg Base/5    Solution; Oral..  Sandoz.
                                            Hydrochloride.    mL.
NDA 020636.............  VIRAMUNE........  Nevirapine......  200 mg..........  Tablet; Oral....  Boehringer
                                                                                                  Ingelheim.
NDA 020645.............  AMMONUL.........  Sodium Benzoate;  10%; 10% (5       Solution;         Bausch Health.
                                            Sodium            Grams (g)/50      Intravenous.
                                            Phenylacetate.    mL; 5 g/50 mL).
NDA 020934.............  LUXIQ...........  Betamethasone     0.12%...........  Aerosol, Foam;    Norvium
                                            Valerate.                           Topical.          Bioscience.

[[Page 19722]]

 
NDA 021071.............  AVANDIA.........  Rosiglitazone     EQ 2 mg Base; EQ  Tablet; Oral....  Woodward Pharma
                                            Maleate.          4 mg Base.                          Services LLC.
NDA 021160.............  PHOSLO GELCAPS..  Calcium Acetate.  667 mg..........  Capsule; Oral...  Fresenius
                                                                                                  Medical Care.
NDA 021360.............  SUSTIVA.........  Efavirenz.......  600 mg..........  Tablet; Oral....  Bristol Myers
                                                                                                  Squibb.
NDA 021493.............  ZYMAR...........  Gatifloxacin....  0.3%............  Solution/Drops;   Allergan.
                                                                                Ophthalmic.
NDA 021656.............  TRICOR..........  Fenofibrate.....  48 mg; 145 mg...  Tablet; Oral....  Abbvie.
NDA 021759.............  ELOXATIN........  Oxaliplatin.....  50 mg/10 mL (5    Injectable;       Sanofi Aventis
                                                              mg/mL); 100 mg/   Intravenous.      US.
                                                              20 mL (5 mg/mL).
NDA 021779.............  VENTAVIS........  Iloprost........  10 Micrograms     Solution;         Actelion.
                                                              (mcg)/mL (10      Inhalation.
                                                              mcg/mL); 20 mcg/
                                                              mL (20 mcg/mL).
NDA 021849.............  ZEGERID.........  Omeprazole;       20 mg, 1.1 g; 40  Capsule; Oral...  Salix.
                                            Sodium            mg, 1.1 g.
                                            Bicarbonate.
NDA 022428.............  MOXEZA..........  Moxifloxacin      EQ 0.5% Base....  Solution/Drops;   Harrow Eye.
                                            Hydrochloride.                      Ophthalmic.
NDA 050006.............  VIBRAMYCIN......  Doxycycline.....  EQ 25 mg Base/5   For Suspension;   Pfizer.
                                                              mL.               Oral.
NDA 050541.............  TOBREX..........  Tobramycin......  0.3%............  Solution/Drops;   Novartis.
                                                                                Ophthalmic.
NDA 050808.............  SOLODYN.........  Minocycline       55 mg; 65 mg; 80  Tablet, Extended  Bausch.
                                            Hydrochloride.    mg; 105 mg; 115   Release; Oral.
                                                              mg.
NDA 207987.............  ABLYSINOL.......  Alcohol.........  99% (1 mL)......  Solution; Intra-  BPI Labs, LLC.
                                                                                Arterial.
NDA 208183.............  ULTRAVATE.......  Halobetasol       0.05%...........  Lotion; Topical.  Lacer
                                            Propionate.                                           Pharmaceutical
                                                                                                  s.
----------------------------------------------------------------------------------------------------------------

    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 
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: May 6, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08207 Filed 5-8-25; 8:45 am]
BILLING CODE 4164-01-P

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