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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2022-N-0412]
 AGENCY: Food and Drug Administration, Department of Health and Human Services (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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily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 005897
FOLVITE
Folic Acid
1 Milligram (mg)
Tablet; Oral
Wyeth Ayerst Pharms.NDA 005897
FOLVITE
Folic Acid
5 mg/Milliliter (mL)
Injectable; Injection
Wyeth Ayerst Pharms.NDA 014691
ALKERAN
Melphalan
2 mg
Tablet; Oral
Apotex Inc.NDA 015923
HALDOL
Haloperidol Lactate
Equivalent to (EQ) 5 mg Base/mL
Injectable; Injection
Janssen Pharms.NDA 016042
DYAZIDE
Hydrochlorothiazide; Triamterene
25 mg; 50 mg, 25 mg; 37.5 mg
Capsule; Oral
GlaxoSmithKline.NDA 017959
ADRUCIL
Fluorouracil
50 mg/mL
Injectable; Injection
Pharmacia & Upjohn Co.NDA 017993
HYDERGINE
Ergoloid Mesylates
0.5 mg, 1 mg
Tablet; Oral
Novartis AG.NDA 018082
DEPAKENE
Valproic Acid
250 mg/5 mL
Syrup; Oral
AbbVie Inc.NDA 018116
CYCLOCORT
Amcinonide
0.025%, 0.1%
Cream; Topical
Astellas.NDA 018498
CYCLOCORT
Amcinonide
0.1%
Ointment; Topical
Astellas.NDA 018985
ORTHO-NOVUM 7/7/7
Ethinyl Estradiol; Norethindrone
0.035 mg; 0.5 mg, 0.035 mg; 0.75 mg, 0.035 mg; 1 mg
Tablet; Oral
Janssen Pharms.NDA 019297
NOVANTRONE
Mitoxantrone Hydrochloride
EQ 20 mg Base/10 mL, EQ 2 mg Base/mL
Injectable; Injection
EMD Serono Inc.NDA 019927
NIZORAL
Ketoconazole
2%
Shampoo; Topical
Janssen Pharms.NDA 020207
ALKERAN
Melphalan Hydrochloride
EQ 50 mg Base/Vial
Injectable; Injection
Apotex Inc.NDA 020262
TAXOL
Paclitaxel
6 mg/mL
Injectable; Injection
HQ Specialty Pharma.NDA 020281
ULTRAM
Tramadol Hydrochloride
100 mg
Tablet; Oral
Janssen Pharms.NDA 021692
ULTRAM ER
Tramadol Hydrochloride
100 mg, 200 mg, 300 mg
Tablet, Extended Release; Oral
Valeant Pharms.NDA 021844
DESONATE
Desonide
0.05%
Gel; Topical
Leo Pharma.NDA 022008
REQUIP XL
Ropinirole Hydrochloride
EQ 2 mg Base, EQ 4 mg Base, EQ 6 mg Base, EQ 8 mg Base, EQ 12 mg Base
Tablet, Extended Release; Oral
GlaxoSmithKline LLC.NDA 050639
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Clindamycin Phosphate
EQ 6 mg Base/mL, EQ 12 mg Base/mL, EQ 18 mg Base/mL
Injectable; Injection
Pfizer.NDA 050684
ZOSYN
Piperacillin Sodium; Tazobactam Sodium
EQ 2 g Base/Vial; EQ 250 mg Base/Vial, EQ 3 g Base/Vial; EQ 375 mg Base/Vial, EQ 4 g Base/Vial; EQ 500 mg Base/Vial, EQ 36 g Base/Vial; EQ 4.5 g Base/Vial
Injectable; Injection
Wyeth Ayerst Pharms.ANDA 062336
MUTAMYCIN
Mitomycin
40 mg/Vial
Injectable; Injection
Bristol-Myers Squibb.
 
 
 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: April 21, 2022. Lauren K. Roth, Associate Commissioner for Policy.


[FR Doc. 2022-08940 Filed 4-26-22; 8:45 am] BILLING CODE 4164-01-P