[Federal Register Volume 86, Number 5 (Friday, January 8, 2021)]
[Notices]
[Pages 1516-1517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00118]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2300]
Determination That ARALEN (Chloroquine Phosphate) Oral Tablets,
500 Milligrams, and Other Drug Products Were Not Withdrawn From Sale
for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, 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withdrawn from sale for reasons of safety or effectiveness.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: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
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 known generally 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 006002......................... ARALEN................ Chloroquine Phosphate. 500 milligrams (mg).. Tablet; Oral......... Sanofi-Aventis U.S.
LLC.
NDA 006134......................... DOLOPHINE Methadone 5 mg; 10 mg.......... Tablet; Oral......... Hikma Pharmaceuticals
HYDROCHLORIDE. Hydrochloride. PLC.
NDA 007409......................... BENTYL................ Dicyclomine 10 mg................ Capsule; Oral........ Allergan
Hydrochloride. Pharmaceuticals.
Dicyclomine 20 mg................ Tablet; Oral.........
Hydrochloride.
NDA 008085......................... Methotrexate Sodium... Methotrexate Sodium... Equivalent to (EQ) Tablet; Oral......... DAVA Pharmaceuticals,
2.5 mg Base. Inc.
NDA 008678......................... Isoniazid............. Isoniazid............. 100 mg; 300 mg....... Tablet; Oral......... Sandoz.
NDA 012945......................... DIAMOX................ Acetazolamide......... 500 mg............... Extended-Release Teva Branded
Capsule; Oral. Pharmaceutical
Products.
NDA 014103......................... ONCOVIN............... Vincristine Sulfate... 1 mg/milliliter (mL); Injectable; Injection Eli Lilly and Co.
1 mg/Vial; 5 mg/Vial.
NDA 016792......................... SURMONTIL............. Trimipramine Maleate.. EQ 25 mg/Base; EQ 50 Capsule; Oral........ Teva Women's Health,
mg/Base; EQ 100 mg/ Inc.
Base.
[[Page 1517]]
NDA 016801......................... XYLOCAINE PRESERVATIVE Lidocaine 1%; 2%; 4%; 10%; 20%. Injectable; Injection Fresenius Kabi USA,
FREE. Hydrochloride. LLC.
NDA 018238......................... MICRO-K............... Potassium Chloride.... 8 milliequivalents Extended-Release Nesher
(mEq); 10 mEq. Capsule; Oral. Pharmaceuticals LLC.
NDA 019568......................... DERMATOP.............. Prednicarbate......... 0.10%................ Ointment; Topical.... Valeant
Pharmaceuticals.
NDA 020192......................... LAMISIL............... Terbinafine 1%................... Cream; Topical....... Novartis.
Hydrochloride.
NDA 020482......................... PRECOSE............... Acarbose.............. 25 mg; 50 mg; 100 mg. Tablet; Oral......... Bayer Healthcare.
NDA 020591......................... TARKA................. Trandolapril; 1 mg; 240 mg......... Extended-Release AbbVie Inc.
Verapamil Tablet; Oral.
Hydrochloride.
NDA 020635......................... LEVAQUIN.............. Levofloxacin.......... EQ 500 mg/20 mL; EQ Injectable; Injection Janssen
750 mg/30 mL. Pharmaceuticals,
Inc.
NDA 020823......................... EXELON................ Rivastigmine Tartrate. EQ 1.5 mg Base; EQ 3 Capsule; Oral........ Novartis.
mg Base; EQ 4.5 mg
Base; EQ 6 mg Base.
NDA 020920......................... NATRECOR.............. Nesiritide............ 1.5 mg/Vial.......... For Solution; Scios Inc.
Intravenous.
NDA 021549......................... EMEND................. Aprepitant............ 40 mg................ Capsule; Oral........ Merck.
NDA 021590......................... FAZACLO ODT........... Clozapine............. 12.5 mg; 25 mg; 100 Orally Disintegrating Jazz Pharmaceuticals
mg; 150 mg; and 200 Tablet; Oral. PLC.
mg.
NDA 202535......................... PREPOPIK.............. Citric Acid, Magnesium 12 grams (g)/Packet; For Solution; Oral... Ferring
Oxide, and Sodium 3.5 g/Packet; 10 mg/ Pharmaceuticals Inc.
Picosulfate. Packet.
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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 NDAs and ANDAs listed are
unaffected by the discontinued marketing of the products subject to
those NDAs and ANDAs. 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: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00118 Filed 1-7-21; 8:45 am]
BILLING CODE 4164-01-P