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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2023-N-4319]
 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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30.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. Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
ApplicantNDA 008922
CALCIUM DISODIUM VERSENATE
Edetate Calcium Disodium
200 Milligrams (mg)/Milliliter (mL)
Injectable; Injection
Bausch Health US, LLC.NDA 011722
TENUATE
Diethylpropion Hydrochloride
25 mg
Tablet; Oral
Nostrum Labs., Inc.NDA 012546
TENUATE DOSPAN
Diethylpropion Hydrochloride
75 mg
Tablets, Extended-Release; Oral
Do.NDA 019117
FLUOCINONIDE
Fluocinonide
0.05%
Cream; Topical
Taro Pharms. U.S.A., Inc.NDA 019796
ELOCON
Mometasone Furoate
0.1%
Lotion; Topical
Organon, LLC.NDA 020489
ANDRODERM
Testosterone
2 mg/24 hours; 4 mg/24 hours
Film, Extended Release; Transdermal
AbbVie Inc.NDA 020884
AGGRENO
                            X
Aspirin; Dipyridamole
25 mg; 200 mg
Capsule, Extended Release; Oral
Boehringer Ingelheim Pharms., Inc.NDA 020903
REBETOL
Ribavirin
200 mg
Capsule; Oral
Merck Sharp and Dohme Corp.NDA 020907
ACTIVELLA
Estradiol; Norethindrone Acetate
0.5 mg; 0.1 mg
Tablet; Oral
Amneal Pharms., LLC.NDA 020949
ACCUNEB
Albuterol Sulfate
Equivalent to (EQ) 0.021% Base; EQ 0.042% Base
Solution; Inhalation
Mylan Specialty LP.NDA 021022
PENLAC
Ciclopirox
8%
Solution; Topical
Valeant International Bermuda.NDA 021449
HEPSERA
Adefovir Dipivoxil
10 mg
Tablet; Oral
Gilead Sciences, Inc.NDA 022052
ZYFLO CR
Zileuton
600 mg
Tablet, Extended Release; Oral
Chiesi USA, Inc.NDA 022511
VIMOVO
Esomeprazole Magnesium; Naproxen
EQ 20 mg Base; 375 mg; EQ 20 mg Base; 500 mg
Tablet, Delayed Release; Oral
Horizon Medicines LLC.NDA 022569
LAZANDA
Fentanyl Citrate
EQ 0.1mg Base; EQ 0.3 mg Base; EQ 0.4 mg Base
Spray, Metered; Nasal
BTcP Pharma, LLC.NDA 202788
SUBSYS
Fentanyl
0.1 mg; 0.2 mg; 0.4 mg; 0.6 mg; 0.8 mg; 1.2 mg; 1.6 mg
Spray; Sublingual
Do.NDA 213645
DAPZURA RT
Daptomycin
500 mg/Vial
Powder; Intravenous
Baxter Healthcare Corp.
 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 
                    ( print page 75003)
                    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: October 27, 2023. Lauren K. Roth, Associate Commissioner for Policy.


[FR Doc. 2023-24120 Filed 10-31-23; 8:45 am] BILLING CODE 4164-01-P