[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64928-64929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17649]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3531]
Determination That DELATESTRYL (Testosterone Enanthate)
Injection, 200 Milligrams/Milliliter, 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Withdrawn From Sale for Reasons of Safety or Effectiveness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withdrawn from sale for reasons of safety or effectiveness.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,
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 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.
[[Page 64929]]
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) Strength(s) route Applicant
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NDA 009165............ DELATESTRYL..... Testosterone 200 Milligrams Injectable; Endo
Enanthate. (mg)/Milliliter Injection. Pharmaceuticals
(mL). Inc.
NDA 011145............ DIURIL.......... Chlorothiazide Equivalent to Injectable; Rising Pharma
Sodium. (EQ) 500 mg Injection. Holdings Inc.
base/Vial.
NDA 013217............ SKELAXIN........ Metaxalone...... 800 mg.......... Tablet; Oral.... King
Pharmaceuticals
Research and
Development
LLC, a
subsidiary of
Pfizer Inc.
NDA 017710............ NALFON.......... Fenoprofen EQ 600 mg Base.. Tablet; Oral.... Dista Products
Calcium. Co., a division
of Eli Lilly
and Co.
NDA 018716............ TRANDATE........ Labetalol 100 mg; 200 mg; Tablet; Oral.... Alvogen Inc.
Hydrochloride. 300 mg.
NDA 018827............ LOTRISONE....... Betamethasone EQ 0.05% Base; Cream; Topical.. Organon LLC, a
Dipropionate; 1%. subsidiary of
Clotrimazole. Organon and Co.
NDA 020080............ IMITREX......... Sumatriptan EQ 6 mg Base/0.5 Injectable; GlaxoSmithKline.
Succinate. mL (EQ 12 mg Subcutaneous.
Base/mL).
NDA 020617............ PYTEST KIT...... Urea, C-14...... 1 mCi........... Capsule; Oral... Avent Inc.
NDA 020763............ AMERGE.......... Naratriptan EQ 1 mg Base; EQ Tablet; Oral.... GlaxoSmithKline.
Hydrochloride. 2.5 mg Base.
NDA 020897............ DITROPAN XL..... Oxybutynin 5 mg; 10 mg..... Tablet, Extended Janssen
Chloride. Release; Oral. Pharmaceuticals
Inc.
NDA 020918............ GLUCAGEN........ Glucagon EQ 1 mg Base/ Injectable; Novo Nordisk
Hydrochloride. Vial. Injection. Pharmaceuticals
Inc.
NDA 020928............ GLUCAGON........ Glucagon........ 1 mg/Vial....... Injectable; Eli Lilly and
Injection. Co.
NDA 021615............ RAZADYNE ER..... Galantamine EQ 8 mg Base; EQ Capsule, Janssen
Hydrobromide. 16 mg Base; EQ Extended Pharmaceuticals
24 mg Base. Release; Oral. Inc.
NDA 021627............ NAMENDA......... Memantine 2 mg/mL......... Solution; Oral.. Allergan Sales
Hydrochloride. LLC.
NDA 021652............ EPZICOM......... Abacavir EQ 600 mg Base, Tablet; Oral.... ViiV Healthcare
Sulfate; 300 mg. Co.
Lamivudine.
NDA 021743............ TARCEVA......... Erlotinib EQ 25 mg Base; Tablet; Oral.... OSI
Hydrochloride. EQ 100 mg Base; Pharmaceuticals
EQ 150 mg Base. LLC.
NDA 021892............ OSMOPREP........ Sodium 0.398 grams Tablet; Oral.... Salix
Phosphate, (g)m; 1.102 (g). Pharmaceuticals
Dibasic, Inc.
Anhydrous;
Sodium
Phosphate,
Monobasic,
Monohydrate.
NDA 022013............ OLUX E.......... Clobetasol 0.05%........... Aerosol, Foam; Mylan
Propionate. Topical. Pharmaceuticals
Inc.
NDA 022204............ GELNIQUE........ Oxybutynin 10% (100 mg/ Gel; Transdermal Abbvie Inc.
Chloride. Packet).
NDA 022525............ NAMENDA XR...... Memantine 7 mg............ Capsule, Abbvie Inc.
Hydrochloride. Extended
Release; Oral.
NDA 050168............ CORTISPORIN..... Bacitracin Zinc; 400 units/g 1%, Ointment; Monarch
Hydrocortisone; EQ 3.5 mg Base/ Topical. Pharmaceuticals
Neomycin g, 5,000 units/ LLC.
Sulfate; g.
Polymyxin B
Sulfate.
NDA 050218............ CORTISPORIN..... Hydrocortisone 0.5%, EQ 3.5 mg Cream; Topical.. Monarch
Acetate; Base/g, 10,000 Pharmaceuticals
Neomycin units/g. LLC.
Sulfate;
Polymyxin B
Sulfate.
NDA 050278............ ACHROMYCIN V.... Tetracycline 250 mg; 500 mg.. Capsule; Oral... Avet
Hydrochloride. Pharmaceuticals
Inc.
NDA 050578............ FORTAZ.......... Ceftazidime..... 500 mg/Vial; 1 g/ Injectable; PAI Holdings LLC
Vial; 2 g/Vial; Injection. DBA
6 g/Vial. Pharmaceutical
Associates Inc.
NDA 050679............ MAXIPIME........ Cefepime EQ 500 mg Base/ Injectable; Hospira Inc.
Hydrochloride. Vial; EQ 1 g Injection.
Base/Vial; EQ 2
g Base/Vial.
NDA 202543............ LEVETIRACETAM IN Levetiracetam... 250 mg/50 mL (5 Injectable; HQ Specialty
SODIUM CHLORIDE. mg/mL). Intravenous. Pharma Corp.
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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: August 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17649 Filed 8-7-24; 8:45 am]
BILLING CODE 4164-01-P