[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Milligram, and Other Drug Products, Were Not Withdrawn From Sale for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withdrawn from sale for reasons of safety or effectiveness.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,
[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.
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Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant
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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