[Federal Register Volume 89, Number 234 (Thursday, December 5, 2024)]
[Notices]
[Pages 96654-96655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28433]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5354]
Determination That Bentyl Preservative Free (Dicyclomine
Hydrochloride) Injection, 10 Milligrams/Milliliters, 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Products Were Not Withdrawn From Sale for Reasons of Safety or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withdrawn from sale for reasons of safety or effectiveness.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 008370............. BENTYL Dicyclomine Injectable; 10 Milligrams AbbVie.
PRESERVATIVE Hydrochloride. Injection. (mg)/
FREE. Milliliters
(mL).
NDA 012104............. KENALOG......... Triamcinolone Spray; Topical.. 0.147 mg/Gram Sun
Acetonide. (g). Pharmaceutical
Industries
Limited.
NDA 017806............. THALLOUS Thallous Injectable; 1 Millicurie Lantheus.
CHLORIDE TL 201. Chloride TL-201. Intravenous. (mCi)/mL; 2 mCi/
mL.
NDA 017823............. HALOG........... Halcinonide..... Solution; 0.10%........... Sun
Topical. Pharmaceutical
Industries
Limited.
NDA 018849............. LIDEX........... Fluocinonide.... Solution; 0.05%........... Alvogen.
Topical.
NDA 020551............. NIMBEX.......... Cisatracurium Injectable; Equivalent to AbbVie.
Besylate. Injection. (EQ) 2 mg Base/
mL.
NDA 020551............. NIMBEX Cisatracurium Injectable; EQ 2 mg Base/mL; AbbVie.
PRESERVATIVE Besylate. Injection. EQ 10 mg Base/
FREE. mL.
[[Page 96655]]
NDA 020837............. XOPENEX......... Levalbuterol Solution; EQ 0.0103% Base; Hikma.
Hydrochloride. Inhalation. EQ 0.021% Base;
EQ 0.042% Base;
EQ 0.25% Base.
NDA 020857............. COMBIVIR........ Lamivudine; Tablet; Oral.... 150 mg; 300 mg.. Viiv Health
Zidovudine. Care.
NDA 020977............. ZIAGEN.......... Abacavir Sulfate Tablet; Oral.... EQ 300 mg Base.. Viiv Health
Care.
NDA 021205............. TRIZIVIR........ Abacavir Tablet; Oral.... EQ 300 mg Base, Viiv Health
Sulfate, 150 mg, 300 mg. Care.
Lamivudine,
Zidovudine.
NDA 021223............. ZOMETA.......... Zoledronic Acid. Injectable; EQ 4 mg Base/100 Novartis.
Intravenous. mL; EQ 4 mg
Base/5 mL.
NDA 021548............. LEXIVA.......... Fosamprenavir Tablet; Oral.... EQ 700 mg Base.. Viiv Health
Calcium. Care.
NDA 021695............. ANTARA Fenofibrate..... Capsule; Oral... 90 mg........... Lupin.
(MICRONIZED).
NDA 021738............. EXTINA.......... Ketoconazole.... Aerosol, Foam; 2%.............. Mylan.
Topical.
NDA 021861............. PATANASE........ Olopatadine Spray, Metered; 0.665 mg/Spray.. Novartis.
Hydrochloride. Nasal.
NDA 022128............. SELZENTRY....... Maraviroc....... Tablet; Oral.... 25 mg; 75 mg.... Viiv Health
Care.
NDA 022350............. ONGLYZA......... Saxagliptin Tablet; Oral.... EQ 2.5 mg Base; AstraZeneca AB.
Hydrochloride. EQ 5 mg Base.
NDA 050440............. KEFLET.......... Cephalexin...... Tablet; Oral.... EQ 250 mg Base; Eli Lilly and
EQ 500 mg Base. Company.
NDA 050558............. ZINACEF......... Cefuroxime Injectable; EQ 750 mg Base/ PAI Pharma.
Sodium. Intramuscular, Vial; EQ 1.5 g
Intravenous. Base/Vial; EQ
7.5 g Base/Vial.
NDA 050567............. POLYTRIM........ Polymyxin B Solution/Drops; 10,000 Units/mL, Allergan.
Sulfate, Ophthalmic. EQ 1 mg Base/mL.
Trimethoprim
Sulfate.
NDA 050588............. CEFOTAN......... Cefotetan Injectable; EQ 10 g Base/ PAI Pharma.
Disodium. Injection. Vial.
NDA 050795............. DORYX........... Doxycycline Tablet, Delayed EQ 75 mg Base; Mayne Pharma.
Hyclate. Release; Oral. EQ 150 mg Base.
NDA 200678............. KOMBIGLYZE XR... Metformin Tablet, Extended 500 mg, EQ 5 mg AstraZeneca AB.
Hydrochloride, Release; Oral. Base; 1 g, EQ 5
Saxagliptin mg Base; 1 g,
Hydrochloride. EQ 2.5 mg Base.
NDA 201194............. OXYCODONE Oxycodone Solution; Oral.. 5 mg/5 mL....... VistaPharm,
HYDROCHLORIDE. Hydrochloride. LLC.
NDA 204427............. KERYDIN......... Tavaborole...... Solution; 5%.............. Anacor
Topical. Pharmaceutical
s, Inc.
NDA 204592............. ZORVOLEX........ Diclofenac...... Capsule; Oral... 35 mg........... Zyla.
NDA 204790............. TIVICAY......... Dolutegravir Tablet; Oral.... EQ 10 mg Base; Viiv Health
Sodium. EQ 25 mg Base. Care.
NDA 215868............. MIDAZOLAM IN Midazolam....... Solution; 50 mg/50 mL (1 Exela Pharma.
0.8% SODIUM Intravenous. mg/mL).
CHLORIDE.
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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: November 27, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-28433 Filed 12-4-24; 8:45 am]
BILLING CODE 4164-01-P