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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2024-N-5354]
 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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30.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. Table 1—Drug Products Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Application No.
Drug name
Active ingredient(s)
Dosage form/route
Strength(s)
ApplicantNDA 008370
BENTYL PRESERVATIVE FREE
Dicyclomine Hydrochloride
Injectable; Injection
10 Milligrams (mg)/Milliliters (mL)
AbbVie.NDA 012104
KENALOG
Triamcinolone Acetonide
Spray; Topical
0.147 mg/Gram (g)
Sun Pharmaceutical Industries Limited.NDA 017806
THALLOUS CHLORIDE TL 201
Thallous Chloride TL-201
Injectable; Intravenous
1 Millicurie (mCi)/mL; 2 mCi/mL
Lantheus.NDA 017823
HALOG
Halcinonide
Solution; Topical
0.10%
Sun Pharmaceutical Industries Limited.NDA 018849
LIDEX
Fluocinonide
Solution; Topical
0.05%
Alvogen.NDA 020551
NIMBEX
Cisatracurium Besylate
Injectable; Injection
Equivalent to (EQ) 2 mg Base/mL
AbbVie.NDA 020551
NIMBEX PRESERVATIVE FREE
Cisatracurium Besylate
Injectable; Injection
EQ 2 mg Base/mL; EQ 10 mg Base/mL
AbbVie.( print page 96655)NDA 020837
XOPENEX
Levalbuterol Hydrochloride
Solution; Inhalation
EQ 0.0103% Base; EQ 0.021% Base; EQ 0.042% Base; EQ 0.25% Base
Hikma.NDA 020857
COMBIVIR
Lamivudine; Zidovudine
Tablet; Oral
150 mg; 300 mg
Viiv Health Care.NDA 020977
ZIAGEN
Abacavir Sulfate
Tablet; Oral
EQ 300 mg Base
Viiv Health Care.NDA 021205
TRIZIVIR
Abacavir Sulfate, Lamivudine, Zidovudine
Tablet; Oral
EQ 300 mg Base, 150 mg, 300 mg
Viiv Health Care.NDA 021223
ZOMETA
Zoledronic Acid
Injectable; Intravenous
EQ 4 mg Base/100 mL; EQ 4 mg Base/5 mL
Novartis.NDA 021548
LEXIVA
Fosamprenavir Calcium
Tablet; Oral
EQ 700 mg Base
Viiv Health Care.NDA 021695
ANTARA (MICRONIZED)
Fenofibrate
Capsule; Oral
90 mg
Lupin.NDA 021738
EXTINA
Ketoconazole
Aerosol, Foam; Topical
2%
Mylan.NDA 021861
PATANASE
Olopatadine Hydrochloride
Spray, Metered; Nasal
0.665 mg/Spray
Novartis.NDA 022128
SELZENTRY
Maraviroc
Tablet; Oral
25 mg; 75 mg
Viiv Health Care.NDA 022350
ONGLYZA
Saxagliptin Hydrochloride
Tablet; Oral
EQ 2.5 mg Base; EQ 5 mg Base
AstraZeneca AB.NDA 050440
KEFLET
Cephalexin
Tablet; Oral
EQ 250 mg Base; EQ 500 mg Base
Eli Lilly and Company.NDA 050558
ZINACEF
Cefuroxime Sodium
Injectable; Intramuscular, Intravenous
EQ 750 mg Base/Vial; EQ 1.5 g Base/Vial; EQ 7.5 g Base/Vial
PAI Pharma.NDA 050567
POLYTRIM
Polymyxin B Sulfate, Trimethoprim Sulfate
Solution/Drops; Ophthalmic
10,000 Units/mL, EQ 1 mg Base/mL
Allergan.NDA 050588
CEFOTAN
Cefotetan Disodium
Injectable; Injection
EQ 10 g Base/Vial
PAI Pharma.NDA 050795
DORYX
Doxycycline Hyclate
Tablet, Delayed Release; Oral
EQ 75 mg Base; EQ 150 mg Base
Mayne Pharma.NDA 200678
KOMBIGLYZE XR
Metformin Hydrochloride, Saxagliptin Hydrochloride
Tablet, Extended Release; Oral
500 mg, EQ 5 mg Base; 1 g, EQ 5 mg Base; 1 g, EQ 2.5 mg Base
AstraZeneca AB.NDA 201194
OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride
Solution; Oral
5 mg/5 mL
VistaPharm, LLC.NDA 204427
KERYDIN
Tavaborole
Solution; Topical
5%
Anacor Pharmaceuticals, Inc.NDA 204592
ZORVOLEX
Diclofenac
Capsule; Oral
35 mg
Zyla.NDA 204790
TIVICAY
Dolutegravir Sodium
Tablet; Oral
EQ 10 mg Base; EQ 25 mg Base
Viiv Health Care.NDA 215868
MIDAZOLAM IN 0.8% SODIUM CHLORIDE
Midazolam
Solution; Intravenous
50 mg/50 mL (1 mg/mL)
Exela Pharma.
 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: 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