[Federal Register Volume 88, Number 93 (Monday, May 15, 2023)]
[Notices]
[Pages 30989-30990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10296]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1703]


Determination That CATAPRES (Clonidine Hydrochloride) Tablets, 
0.1 Milligrams; 0.2 Milligrams; and 0.3 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Products Were Not Withdrawn From Sale for Reasons of Safety or 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withdrawn from sale for reasons of safety or effectiveness.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: 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.

----------------------------------------------------------------------------------------------------------------
                                             Active
  Application No.       Drug name        ingredient(s)       Strength(s)     Dosage form/route      Applicant
----------------------------------------------------------------------------------------------------------------
NDA 017407........  CATAPRES.........  Clonidine          0.1 Milligrams     Tablet; Oral.....  Boehringer
                                        Hydrochloride.     (mg); 0.2 mg;                         Ingelheim.
                                                           0.3 mg.
NDA 017534........  FIORINAL.........  Aspirin;           325 mg; 50 mg; 40  Capsule; Oral....  Allergan Sales.
                                        Butalbital;        mg.
                                        Caffeine.

[[Page 30990]]

 
NDA 017876........  LOESTRIN 21 1/20.  Ethinyl            0.02 mg; 1 mg....  Tablet; Oral.....  Teva Branded
                                        Estradiol;                                               Pharms.
                                        Norethindrone
                                        Acetate.
NDA 018647........  CORZIDE..........  Bendroflumethiazi  5 mg; 40 mg; 5     Tablet; Oral.....  King Pharms.,
                                        de; Nadolol.       mg; 80 mg.                            LLC.
NDA 018685........  GAVISCON.........  Aluminum           80 mg; 20 mg; 160  Tablet; Oral.....  Chattem.
                                        Hydroxide;         mg, 40 mg.
                                        Magnesium
                                        Trisilicate.
NDA 018751........  SPECTAZOLE.......  Econazole Nitrate  1%...............  Cream; Topical...  Alvogen, Inc.
NDA 019813........  DURAGESIC-100....  Fentanyl.........  100 Micrograms     Film, Extended     Janssen Pharms.
                                                           (mcg)/Hour; 12.5   Release;
                                                           mcg/Hour; 25 mcg/  Transdermal.
                                                           Hour; 37.5 mcg/
                                                           Hour; 50 mcg/
                                                           Hour; 75 mcg/
                                                           Hour.
NDA 020519........  CICLOPIROX.......  Ciclopirox.......  0.77%............  Gel; Topical.....  Alvogen, Inc.
NDA 021015........  ANDROGEL.........  Testosterone.....  25 mg/2.5 Grams    Gel; Transdermal.  Besins
                                                           (g) Packet; 50                        Healthcare.
                                                           mg/5 g Packet.
NDA 021152........  CUTIVATE.........  Fluticasone        0.05%............  Lotion; Topical..  Fougera Pharms.
                                        Propionate.
NDA 021169........  RAZADYNE.........  Galantamine        Equivalent to      Tablet; Oral.....  Janssen Pharms.
                                        Hydrobromide.      (EQ) 4 mg Base;
                                                           EQ 8 mg Base; EQ
                                                           12 mg Base.
NDA 021567........  REYATAZ..........  Atazanavir         EQ 150 mg Base...  Capsule; Oral....  Bristol Myers
                                        Sulfate.                                                 Squibb.
NDA 021695........  ANTARA             Fenofibrate......  30 mg............  Capsule; Oral....  Lupin.
                     (MICRONIZED).
NDA 022107........  TEKTURNA HCT.....  Aliskiren          EQ 150 mg Base;    Tablet; Oral.....  Noden Pharma.
                                        Hemifumarate;      12.5 mg; EQ 150
                                        Hydrochlorothiaz   mg Base; 25 mg;
                                        ide.               300 mg; 12.5 mg;
                                                           300 mg; 25 mg.
NDA 022309........  ANDROGEL.........  Testosterone.....  1.62% (20.25 mg/   Gel; Transdermal.  Besins
                                                           1.25 g Packet);                       Healthcare.
                                                           1.62% (40.5 mg/
                                                           2.5 g Packet).
NDA 022401........  TWYNSTA..........  Amlodipine         EQ 5 mg Base; 40   Tablet; Oral.....  Boehringer
                                        Besylate;          mg; EQ 10 mg                          Ingelheim.
                                        Telmisartan.       Base; 40 mg; EQ
                                                           5 mg Base; 80
                                                           mg; EQ 10 mg
                                                           Base; 80 mg.
NDA 022426........  OSENI............  Alogliptin         EQ 12.5 mg Base;   Tablet; Oral.....  Takeda Pharms.
                                        Benzoate;          EQ 15 mg Base;                        USA.
                                        Pioglitazone       EQ 12.5 mg Base;
                                        Hydrochloride.     EQ 45 mg Base.
NDA 050824........  OMEPRAZOLE AND     Amoxicillin;       500 mg, n/a, n/a;  Capsule, Tablet,   Cumberland
                     CLARITHROMYCIN     Clarithromycin;    n/a, 500 mg, n/    Capsule, Delayed   Pharms.
                     AND AMOXICILLIN.   Omeprazole.        a; n/a, n/a, 20    Release; Oral.
                                                           mg.
----------------------------------------------------------------------------------------------------------------

    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: May 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10296 Filed 5-12-23; 8:45 am]
BILLING CODE 4164-01-P


