[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500 Milligrams, and Other Drug Products Were Not Withdrawn From Sale 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withdrawn from sale for reasons of safety or effectiveness.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, 
<a href="/cdn-cgi/l/email-protection#de8daabfbda7f095bfb0bb9eb8babff0b6b6adf0b9b1a8"><span class="__cf_email__" data-cfemail="c596b1a4a6bceb8ea4aba085a3a1a4ebadadb6eba2aab3">[email protected]</span></a>.

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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


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