[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Drops; and Other Drug Products Were Not Withdrawn From Sale for Reasons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.
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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withdrawn from sale for reasons of safety or effectiveness.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,
[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
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Active Dosage form/
Application No. Drug name ingredient(s) route Strength(s) Applicant
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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.
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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