[Federal Register Volume 89, Number 69 (Tuesday, April 9, 2024)]
[Notices]
[Pages 24841-24842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07494]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1569]
Determination That NALFON (Fenoprofen Calcium) Oral Capsules,
Equivalent to 300 Milligram Base, 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Withdrawn From Sale for Reasons of Safety or Effectiveness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withdrawn from sale for reasons of safety or effectiveness.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.
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Active Dosage form/
Application No. Drug name ingredient(s) Strength(s) route Applicant
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NDA 017604............. NALFON.......... Fenoprofen Equivalent to Capsule; Oral... Xspire Pharma.
Calcium. (EQ) 300
Milligrams (mg)
Base.
NDA 017087............. ETHRANE......... Enflurane....... 99.9%........... Liquid; Baxter
Inhalation. Healthcare
Corp.
NDA 018801............. STERILE WATER Sterile Water 100% (1 Liquid; N/A..... Hospira, A
FOR INJECTION. For Injection. Milliliter Pfizer
(mL)); 100% Company.
(5.2 mL).
NDA 019152............. CALAN SR........ Verapamil 120 mg; 180 mg, Tablet, Extended Pfizer Inc.
Hydrochloride. 240 mg. Release; Oral.
NDA 019885............. ACCUPRIL........ Quinapril EQ 5 mg Base; EQ Tablet; Oral.... Pfizer
Hydrochloride. 10 mg Base; EQ Pharmaceutical
20 mg Base; EQ s Ltd.
40 mg Base.
[[Page 24842]]
NDA 019941............. EMLA............ Lidocaine; 2.5%; 2.5%...... Cream; Topical.. Teva Branded
Prilocaine. Pharmaceutical
Products R & D
Inc.
NDA 020105............. TRIOSTAT........ Liothyronine EQ 0.01 mg Base/ Injectable; Par Sterile
Sodium. mL. Injection. Products, LLC.
NDA 020125............. ACCURETIC....... Hydrochlorothiaz 12.5 mg, EQ 10 Tablet; Oral.... Pfizer
ide; Quinapril mg Base; 12.5 Pharmaceutical
Hydrochloride. mg, EQ 20 mg s Ltd.
Base; 25 mg, EQ
20 mg Base.
NDA 020406............. PREVACID........ Lansoprazole.... 15 mg........... Capsule, Delayed Takeda
Release Pharmaceutical
Pellets; Oral. s USA, Inc.
NDA 020666............. ALBENZA......... Albendazole..... 200 mg.......... Tablet; Oral.... Impax
Laboratories
Inc.
NDA 020723............. ALDARA.......... Imiquimod....... 5%.............. Cream; Topical.. Bausch Health
US LLC.
NDA 020972............. SUSTIVA......... Efavirenz....... 50 mg; 200 mg... Capsule; Oral... Bristol Myers
Squibb Co.
NDA 021009............. ALOCRIL......... Nedocromil 2%.............. Solution/Drops; Allergan Inc.
Sodium. Ophthalmic.
NDA 021526............. RANEXA.......... Ranolazine...... 500 mg; 1 g..... Tablet, Extended Menarini
Release; Oral. International
Operations
Luxembourg SA.
NDA 021565............. ELESTAT......... Epinastine 0.05%........... Solution/Drops; Allergan Inc.
Hydrochloride. Ophthalmic.
NDA 021775............. ENTEREG......... Alvimopan....... 12 mg........... Capsule; Oral... Cubist
Pharmaceutical
s, Inc.
NDA 021790............. DACOGEN......... Decitabine...... 50 mg/Vial...... Injectable; Otsuka
Intravenous. Pharmaceutical
Co., Ltd.
NDA 050095............. CAPASTAT SULFATE Capreomycin EQ 1 g Base/Vial Injectable; Epic Pharma,
Sulfate. Injection. LLC.
NDA 050795............. DORYX........... Doxycycline EQ 50 mg Base; Tablet, Delayed Mayne Pharma
Hyclate. EQ 100 mg Base; Release; Oral. International
EQ 120 mg Base. Pty Ltd.
NDA 050801............. EVOCLIN......... Clindamycin 1%.............. Aerosol, Foam; Mylan
Phosphate. Topical. Pharmaceutical
s Inc.
NDA 200179............. STAXYN.......... Vardenafil 10 mg........... Tablet, Orally Bayer
Hydrochloride. Disintegrating; Healthcare
Oral. Pharmaceutical
s Inc.
NDA 202515............. MORPHINE SULFATE Morphine Sulfate 15 mg/mL........ Injectable; Hospira, A
Injection. Pfizer
Company.
NDA 203667............. MINASTRIN 24 FE. Ethinyl 0.02mg, 1mg..... Tablet; Oral.... Allergan
Estradiol; Pharmaceutical
Norethindrone s
Acetate. International,
Ltd.
NDA 210854............. XOFLUZA......... Baloxavir 20 mg........... Tablet; Oral.... Genentech, Inc.
Marboxil.
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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: April 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07494 Filed 4-8-24; 8:45 am]
BILLING CODE 4164-01-P