[Federal Register Volume 87, Number 81 (Wednesday, April 27, 2022)]
[Notices]
[Pages 25028-25029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08940]



[[Page 25028]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0412]


Determination That FOLVITE (Folic Acid), Oral Tablets, 1 
Milligram, and Other Drug Products, Were Not Withdrawn From Sale for 
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (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withdrawn from sale for reasons of safety or effectiveness.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, 
<a href="/cdn-cgi/l/email-protection#0c5f786d6f7522476d62694c6a686d2264647f226b637a"><span class="__cf_email__" data-cfemail="dc8fa8bdbfa5f297bdb2b99cbab8bdf2b4b4aff2bbb3aa">[email protected]</span></a>.

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.

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      Application No.             Drug name         Active ingredient(s)       Strength(s)         Dosage form/route                Applicant
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 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   Injectable; Injection  Janssen Pharms.
                                                                           mg Base/mL.
NDA 016042................  DYAZIDE..............  Hydrochlorothiazide;   25 mg; 50 mg, 25 mg;   Capsule; Oral........  GlaxoSmithKline.
                                                    Triamterene.           37.5 mg.
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;     0.035 mg; 0.5 mg,      Tablet; Oral.........  Janssen Pharms.
                                                    Norethindrone.         0.035 mg; 0.75 mg,
                                                                           0.035 mg; 1 mg.
NDA 019297................  NOVANTRONE...........  Mitoxantrone           EQ 20 mg Base/10 mL,   Injectable; Injection  EMD Serono Inc.
                                                    Hydrochloride.         EQ 2 mg Base/mL.
NDA 019927................  NIZORAL..............  Ketoconazole.........  2%...................  Shampoo; Topical.....  Janssen Pharms.
NDA 020207................  ALKERAN..............  Melphalan              EQ 50 mg Base/Vial...  Injectable; Injection  Apotex Inc.
                                                    Hydrochloride.
NDA 020262................  TAXOL................  Paclitaxel...........  6 mg/mL..............  Injectable; Injection  HQ Specialty Pharma.
NDA 020281................  ULTRAM...............  Tramadol               100 mg...............  Tablet; Oral.........  Janssen Pharms.
                                                    Hydrochloride.
NDA 021692................  ULTRAM ER............  Tramadol               100 mg, 200 mg, 300    Tablet, Extended       Valeant Pharms.
                                                    Hydrochloride.         mg.                    Release; Oral.
NDA 021844................  DESONATE.............  Desonide.............  0.05%................  Gel; Topical.........  Leo Pharma.
NDA 022008................  REQUIP XL............  Ropinirole             EQ 2 mg Base, EQ 4 mg  Tablet, Extended       GlaxoSmithKline LLC.
                                                    Hydrochloride.         Base, EQ 6 mg Base,    Release; Oral.
                                                                           EQ 8 mg Base, EQ 12
                                                                           mg Base.
NDA 050639................  CLEOCIN PHOSPHATE IN   Clindamycin Phosphate  EQ 6 mg Base/mL, EQ    Injectable; Injection  Pfizer.
                             DEXTROSE 5% IN                                12 mg Base/mL, EQ 18
                             PLASTIC CONTAINER.                            mg Base/mL.
NDA 050684................  ZOSYN................  Piperacillin Sodium;   EQ 2 g Base/Vial; EQ   Injectable; Injection  Wyeth Ayerst Pharms.
                                                    Tazobactam Sodium.     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.
ANDA 062336...............  MUTAMYCIN............  Mitomycin............  40 mg/Vial...........  Injectable; Injection  Bristol-Myers Squibb.
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[[Page 25029]]

    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: 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


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