90 FR 89 pgs. 19721-19722 - Determination That VOSOL (Acetic Acid, Glacial) 2% Otic Solution/Drops; and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Type: NOTICEVolume: 90Number: 89Pages: 19721 - 19722
Pages: 19721, 19722Docket number: [Docket No. FDA-2025-N-0679]
FR document: [FR Doc. 2025-08207 Filed 5-8-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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Determination That VOSOL (Acetic Acid, Glacial) 2% Otic Solution/Drops; and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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, 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.
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| Application No. | Drug name | Active ingredient(s) | Dosage form/route | Strength(s) | Applicant |
|---|---|---|---|---|---|
| NDA 012179 | VOSOL | Acetic Acid, Glacial | 2% | Solution/Drops; Otic | Hikma. |
| NDA 012836 | PERSANTINE | Dipyridamole | 25 Milligrams (mg); 50 mg; 75 mg | Tablet; Oral | Boehringer Ingelheim. |
| NDA 013790 | CORDRAN | Flurandrenolide | 0.05% | Lotion; Topical | Almirall. |
| NDA 016758 | NAVANE | Thiothixene Hydrochloride | Equivalent to (EQ) 5 mg Base/Milliliters (mL) | Concentrate; Oral | Pfizer. |
| NDA 017604 | NALFON | Fenoprofen Calcium | EQ 200 mg Base; EQ 400 mg Base | Capsule; Oral | Key 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 Mesylate | EQ 10 mg Base/mL | Injectable; Injection | Hospira. |
| NDA 020212 | ZINECARD | Dexrazoxane Hydrochloride | EQ 250 mg Base/Vial; EQ 500 mg Base/Vial | Injectable; Injection | Pfizer. |
| NDA 020605 | ZOFRAN | Ondansetron Hydrochloride | EQ 4 mg Base/5 mL | Solution; Oral | Sandoz. |
| NDA 020636 | VIRAMUNE | Nevirapine | 200 mg | Tablet; Oral | Boehringer Ingelheim. |
| NDA 020645 | AMMONUL | Sodium Benzoate; Sodium Phenylacetate | 10%; 10% (5 Grams (g)/50 mL; 5 g/50 mL) | Solution; Intravenous | Bausch Health. |
| NDA 020934 | LUXIQ | Betamethasone Valerate | 0.12% | Aerosol, Foam; Topical | Norvium Bioscience. |
| NDA 021071 | AVANDIA | Rosiglitazone Maleate | EQ 2 mg Base; EQ 4 mg Base | Tablet; Oral | Woodward Pharma 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; Ophthalmic | Allergan. |
| NDA 021656 | TRICOR | Fenofibrate | 48 mg; 145 mg | Tablet; Oral | Abbvie. |
| NDA 021759 | ELOXATIN | Oxaliplatin | 50 mg/10 mL (5 mg/mL); 100 mg/20 mL (5 mg/mL) | Injectable; Intravenous | Sanofi Aventis US. |
| NDA 021779 | VENTAVIS | Iloprost | 10 Micrograms (mcg)/mL (10 mcg/mL); 20 mcg/mL (20 mcg/mL) | Solution; Inhalation | Actelion. |
| NDA 021849 | ZEGERID | Omeprazole; Sodium Bicarbonate | 20 mg, 1.1 g; 40 mg, 1.1 g | Capsule; Oral | Salix. |
| NDA 022428 | MOXEZA | Moxifloxacin Hydrochloride | EQ 0.5% Base | Solution/Drops; Ophthalmic | Harrow Eye. |
| NDA 050006 | VIBRAMYCIN | Doxycycline | EQ 25 mg Base/5 mL | For Suspension; Oral | Pfizer. |
| NDA 050541 | TOBREX | Tobramycin | 0.3% | Solution/Drops; Ophthalmic | Novartis. |
| NDA 050808 | SOLODYN | Minocycline Hydrochloride | 55 mg; 65 mg; 80 mg; 105 mg; 115 mg | Tablet, Extended Release; Oral | Bausch. |
| NDA 207987 | ABLYSINOL | Alcohol | 99% (1 mL) | Solution; Intra-Arterial | BPI Labs, LLC. |
| NDA 208183 | ULTRAVATE | Halobetasol Propionate | 0.05% | Lotion; Topical | Lacer Pharmaceuticals. |
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]
BILLING CODE 4164-01-P