[Federal Register Volume 86, Number 55 (Wednesday, March 24, 2021)]
[Notices]
[Pages 15682-15683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06059]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0279]


Determination That 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Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety 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, 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withdrawn from sale for reasons of safety or effectiveness.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, 
Stacy.Kane@fda.hhs.gov.

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 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.

----------------------------------------------------------------------------------------------------------------
                                               Active                           Dosage form/
   Application No.        Drug name        ingredient(s)       Strength(s)          route           Applicant
----------------------------------------------------------------------------------------------------------------
NDA 006135..........  Folic Acid.......  Folic Acid.......  1 milligram (mg)  Tablet; Oral....  Eli Lilly & Co.
NDA 016131..........  CLOMID...........  Clomiphene         50 mg...........  Tablet; Oral....  Sanofi-Aventis
                                          Citrate.                                               U.S. LLC.
NDA 016419..........  Propranolol        Propanolol         1 mg/milliliter   Injectable;       Baxter
                       Hydrochloride.     Hydrochloride.     (mL).             Injection.        Healthcare
                                                                                                 Corp.
NDA 017473..........  ORAP.............  Pimozide.........  1 mg; 2 mg......  Tablet; Oral....  Teva Pharms.,
                                                                                                 USA, Inc.
NDA 019916..........  Morphine Sulfate.  Morphine Sulfate.  1 mg/mL; 5 mg/mL  Injectable;       ICU Medical,
                                                                               Injection.        Inc.
NDA 019967..........  ULTRAVATE........  Halobetasol        0.05%...........  Cream; Topical..  Sun
                                          Propionate.                                            Pharmaceutical
                                                                                                 Industries,
                                                                                                 Inc.
NDA 020647..........  ELDEPRYL.........  Selegiline         5 mg............  Capsule; Oral...  Somerset
                                          Hydrochloride.                                         Pharms., Inc.
NDA 020925..........  TAVIST-1.........  Clemastine         1.34 mg.........  Tablet; Oral....  GlaxoSmithKline
                                          Fumarate.                                              Consumer
                                                                                                 Healthcare.

[[Page 15683]]

 
NDA 021015..........  ANDROGEL.........  Testosterone.....  12.5 mg/1.25 g    Gel, Metered;     AbbVie Inc.
                                                             Actuation.        Transdermal.
NDA 021204..........  STARLIX..........  Nateglinide......  60 mg; 120 mg...  Tablets; Oral...  Novartis
                                                                                                 Pharms., Corp.
NDA 021217..........  EXALGO...........  Hydromorphone      8 mg; 12 mg; 16   Tablet, Extended- Specgx, LLC.
                                          Hydrochloride.     mg; 32 mg.        Release; Oral.
NDA 021365..........  LEXAPRO..........  Escitalopram       Equal to (EQ) 5   Solution; Oral..  Allergan Sales,
                                          Oxalate.           mg Base/5 mL.                       LLC.
NDA 021490..........  FEMCON FE........  Ethinyl            0.035 mg; 0.4 mg  Tablet,           Allergan
                                          Estradiol;                           Chewable; Oral.   Pharms.,
                                          Norethindrone.                                         International,
                                                                                                 Ltd.
NDA 021860..........  SARAFEM..........  Fluoxetine         EQ 15 mg Base...  Tablet; Oral....  Allergan Pharms.
                                          Hydrochloride.                                         International,
                                                                                                 Ltd.
NDA 021870..........  Fludeoxyglucose F- Fludeoxyglucose F- 20-200            Injectable;       Feinstein
                       18.                18.                Millicurie/mL.    Intravenous.      Institute
                                                                                                 Medical
                                                                                                 Research.
NDA 022442..........  REZIRA...........  Hydrocodone        5 mg/5 mL; 60 mg/ Solution; Oral..  Persion Pharms.,
                                          Bitartrate;        5 mL.                               LLC.
                                          Pseudoephedrine
                                          Hydrochloride.
NDA 050757..........  PREVPAC..........  Amoxicillin;       500 mg; 500 mg;   Capsule, Tablet,  Takeda Pharms.
                                          Clarithromycin;    30 mg.            Capsule; Oral.    USA, Inc.
                                          Lansoprazole.
NDA 203195..........  SUPRAX...........  Cefixime.........  400 mg..........  Capsule; Oral...  Lupin, Ltd.
NDA 207931..........  TECHNIVIE........  Ombitasvir;        12.5 mg; 75 mg;   Tablet; Oral....  AbbVie Inc.
                                          Paritaprevir;      50 mg.
                                          Ritonavir.
NDA 208624..........  VIEKIRA XR.......  Dasabuvir Sodium;  EQ 200 mg Base;   Tablet, Extended  AbbVie Inc.
                                          Ombitasvir;        8.33 mg; 50 mg;   Release; Oral.
                                          Paritaprevir;      33.33 mg.
                                          Ritonavir.
----------------------------------------------------------------------------------------------------------------

    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 listed are unaffected by the 
discontinued marketing of the products subject to those NDAs. 
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: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06059 Filed 3-23-21; 8:45 am]
BILLING CODE 4164-01-P


