[Federal Register Volume 85, Number 204 (Wednesday, October 21, 2020)]
[Notices]
[Pages 66994-66995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23300]



[[Page 66994]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2032]


Determination That BUTISOL SODIUM (Butabarbital Sodium) Oral 
Tablets, 15 Milligrams, 50 Milligrams, and 100 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Drug Products Were Not Withdrawn From Sale for Reasons of Safety or 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withdrawn from sale for reasons of safety or effectiveness.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 if 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 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 000793.............  BUTISOL SODIUM..  Butabarbital      15 mg; 50 mg;     Tablet; Oral....  Mylan
                                            Sodium.           100 mg.                             Specialty,
                                                                                                  L.P.
NDA 007392.............  SECONAL SODIUM..  Secobarbital      50 mg/Milliliter  Injectable;       Eli Lilly and
                                            Sodium.           (mL).             Injection.        Co.
NDA 012665.............  VELBAN..........  Vinblastine       10 mg/Vial......  Injectable;       Eli Lilly and
                                            Sulfate.                            Injection.        Co.
NDA 017015.............  PAVULON.........  Pancuronium       1 mg/mL; 2 mg/mL  Injectable;       Schering-Plough
                                            Bromide.                            Injection.        Corp.
NDA 017919.............  ORTHO-NOVUM 1/35- Ethinyl           0.035 mg;1 mg...  Tablet; Oral-28.  Janssen
                          28.               Estradiol;                                            Pharmaceutical
                                            Norethindrone.                                        s, Inc.
NDA 018554.............  EULEXIN.........  Flutamide.......  125 mg..........  Capsule; Oral...  Schering-Plough
                                                                                                  Corp.
NDA 019151.............  RYTHMOL.........  Propafenone       150 mg, 225 mg,   Tablet; Oral....  GlaxoSmithKline
                                            Hydrochloride.    300 mg.                             .
NDA 019579.............  TERAZOL 7.......  Terconazole.....  0.4%............  Cream; Vaginal..  Janssen
                                                                                                  Pharmaceutical
                                                                                                  s, Inc.
NDA 019599.............  NAFTIN..........  Naftifine         1%..............  Cream; Topical..  Sebela Ireland
                                            Hydrochloride.                                        Limited.
NDA 019653.............  ORTHO CYCLEN-28.  Ethinyl           0.035 mg; 0.25    Tablet; Oral-28.  Janssen
                                            Estradiol;        mg.                                 Pharmaceutical
                                            Norgestimate.                                         s, Inc.
NDA 019716.............  DIPROLENE.......  Betamethasone     EQ 0.05% Base...  Lotion,           Merck Sharp &
                                            Dipropionate.                       Augmented;        Dohme Corp.
                                                                                Topical.
NDA 019964.............  TERAZOL 3.......  Terconazole.....  0.8%............  Cream; Vaginal..  Janssen
                                                                                                  Pharmaceutical
                                                                                                  s, Inc.
NDA 020313.............  MIACALCIN.......  Calcitonin        200               Metered Spray;    Mylan Ireland
                                            Salmon.           International     Nasal.            Limited.
                                                              Units/Spray.
NDA 020388.............  NAVELBINE.......  Vinorelbine       EQ 10 mg Base/mL  Injectable;       Pierre Fabre
                                            Tartrate.                           Injection.        Medicament.
NDA 020413.............  ZERIT...........  Stavudine.......  1 mg/mL.........  For Solution;     Bristol-Myers
                                                                                Oral.             Squibb.
NDA 020741.............  PRANDIN.........  Repaglinide.....  0.5 mg; 1 mg; 2   Tablet; Oral....  Gemini
                                                              mg.                                 Laboratories,
                                                                                                  LLC.
NDA 020872.............  CHILDREN'S        Fexofenadine      30 mg...........  Tablet; Oral....  Sanofi-Aventis
                          ALLEGRA ALLERGY.  Hydrochloride.                                        U.S., LLC.
NDA 021071.............  AVANDIA.........  Rosiglitazone     EQ 8 mg Base....  Tablets; Oral...  SB Pharmco
                                            Maleate.                                              Puerto Rico,
                                                                                                  Inc.
NDA 021235.............  PROZAC WEEKLY...  Fluoxetine        EQ 90 mg/Base...  Delayed-Release   Eli Lilly and
                                            Hydrochloride.                      Capsules; Oral.   Co.

[[Page 66995]]

 
NDA 021909.............  CHILDREN'S        Fexofenadine      30 mg...........  Tablet, Orally    Sanofi-Aventis
                          ALLEGRA HIVES.    Hydrochloride.                      Disintegrating;   U.S., LLC.
                                                                                Oral.
NDA 022246.............  METOZOLV ODT....  Metoclopramide    EQ 5 mg Base....  Tablet, Orally    Bausch Health
                                            Hydrochloride.                      Disintegrating;   US, LLC.
                                                                                Oral.
NDA 022291.............  PROMACTA........  Eltrombopag       EQ 100 mg Acid..  Tablet; Oral....  Novartis.
                                            Olamine.
NDA 022362.............  WELCHOL.........  Colesevelam       1.875 g/Packet..  For Suspension;   Daiichi Sankyo.
                                            Hydrochloride.                      Oral.
NDA 022396.............  DYLOJECT........  Diclofenac        37.5 mg/mL (37.5  Solution;         Javelin
                                            Sodium.           mg/mL).           Intravenous.      Pharmaceutical
                                                                                                  s, Inc.
NDA 050368.............  ILOTYCIN........  Erythromycin....  0.5%............  Ointment;         Eli Lilly and
                                                                                Ophthalmic.       Co.
NDA 050587.............  PRIMAXIN........  Cilastatin        EQ 250 mg Base/   Powder;           Merck & Co.,
                                            Sodium;           Vial; 250 mg/     Intravenous.      Inc.
                                            Imipenem.         Vial.
NDA 201373.............  CHILDREN'S        Fexofenadine      30 mg/5 mL......  Suspension; Oral  Sanofi-Aventis
                          ALLEGRA HIVES.    Hydrochloride.                                        U.S., LLC.
NDA 208411.............  NARCAN..........  Naloxone          2 mg/Spray......  Spray, Metered;   Adapt Pharma.
                                            Hydrochloride.                      Nasal.
----------------------------------------------------------------------------------------------------------------

    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: October 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23300 Filed 10-20-20; 8:45 am]
BILLING CODE 4164-01-P