[Federal Register Volume 89, Number 69 (Tuesday, April 9, 2024)]
[Notices]
[Pages 24841-24842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07494]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1569]


Determination That NALFON (Fenoprofen Calcium) Oral Capsules, 
Equivalent to 300 Milligram Base, 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Withdrawn From Sale for Reasons of Safety or Effectiveness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withdrawn from sale for reasons of safety or effectiveness.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                           Dosage form/
    Application No.          Drug name       ingredient(s)      Strength(s)          route          Applicant
----------------------------------------------------------------------------------------------------------------
NDA 017604.............  NALFON..........  Fenoprofen        Equivalent to     Capsule; Oral...  Xspire Pharma.
                                            Calcium.          (EQ) 300
                                                              Milligrams (mg)
                                                              Base.
NDA 017087.............  ETHRANE.........  Enflurane.......  99.9%...........  Liquid;           Baxter
                                                                                Inhalation.       Healthcare
                                                                                                  Corp.
NDA 018801.............  STERILE WATER     Sterile Water     100% (1           Liquid; N/A.....  Hospira, A
                          FOR INJECTION.    For Injection.    Milliliter                          Pfizer
                                                              (mL)); 100%                         Company.
                                                              (5.2 mL).
NDA 019152.............  CALAN SR........  Verapamil         120 mg; 180 mg,   Tablet, Extended  Pfizer Inc.
                                            Hydrochloride.    240 mg.           Release; Oral.
NDA 019885.............  ACCUPRIL........  Quinapril         EQ 5 mg Base; EQ  Tablet; Oral....  Pfizer
                                            Hydrochloride.    10 mg Base; EQ                      Pharmaceutical
                                                              20 mg Base; EQ                      s Ltd.
                                                              40 mg Base.

[[Page 24842]]

 
NDA 019941.............  EMLA............  Lidocaine;        2.5%; 2.5%......  Cream; Topical..  Teva Branded
                                            Prilocaine.                                           Pharmaceutical
                                                                                                  Products R & D
                                                                                                  Inc.
NDA 020105.............  TRIOSTAT........  Liothyronine      EQ 0.01 mg Base/  Injectable;       Par Sterile
                                            Sodium.           mL.               Injection.        Products, LLC.
NDA 020125.............  ACCURETIC.......  Hydrochlorothiaz  12.5 mg, EQ 10    Tablet; Oral....  Pfizer
                                            ide; Quinapril    mg Base; 12.5                       Pharmaceutical
                                            Hydrochloride.    mg, EQ 20 mg                        s Ltd.
                                                              Base; 25 mg, EQ
                                                              20 mg Base.
NDA 020406.............  PREVACID........  Lansoprazole....  15 mg...........  Capsule, Delayed  Takeda
                                                                                Release           Pharmaceutical
                                                                                Pellets; Oral.    s USA, Inc.
NDA 020666.............  ALBENZA.........  Albendazole.....  200 mg..........  Tablet; Oral....  Impax
                                                                                                  Laboratories
                                                                                                  Inc.
NDA 020723.............  ALDARA..........  Imiquimod.......  5%..............  Cream; Topical..  Bausch Health
                                                                                                  US LLC.
NDA 020972.............  SUSTIVA.........  Efavirenz.......  50 mg; 200 mg...  Capsule; Oral...  Bristol Myers
                                                                                                  Squibb Co.
NDA 021009.............  ALOCRIL.........  Nedocromil        2%..............  Solution/Drops;   Allergan Inc.
                                            Sodium.                             Ophthalmic.
NDA 021526.............  RANEXA..........  Ranolazine......  500 mg; 1 g.....  Tablet, Extended  Menarini
                                                                                Release; Oral.    International
                                                                                                  Operations
                                                                                                  Luxembourg SA.
NDA 021565.............  ELESTAT.........  Epinastine        0.05%...........  Solution/Drops;   Allergan Inc.
                                            Hydrochloride.                      Ophthalmic.
NDA 021775.............  ENTEREG.........  Alvimopan.......  12 mg...........  Capsule; Oral...  Cubist
                                                                                                  Pharmaceutical
                                                                                                  s, Inc.
NDA 021790.............  DACOGEN.........  Decitabine......  50 mg/Vial......  Injectable;       Otsuka
                                                                                Intravenous.      Pharmaceutical
                                                                                                  Co., Ltd.
NDA 050095.............  CAPASTAT SULFATE  Capreomycin       EQ 1 g Base/Vial  Injectable;       Epic Pharma,
                                            Sulfate.                            Injection.        LLC.
NDA 050795.............  DORYX...........  Doxycycline       EQ 50 mg Base;    Tablet, Delayed   Mayne Pharma
                                            Hyclate.          EQ 100 mg Base;   Release; Oral.    International
                                                              EQ 120 mg Base.                     Pty Ltd.
NDA 050801.............  EVOCLIN.........  Clindamycin       1%..............  Aerosol, Foam;    Mylan
                                            Phosphate.                          Topical.          Pharmaceutical
                                                                                                  s Inc.
NDA 200179.............  STAXYN..........  Vardenafil        10 mg...........  Tablet, Orally    Bayer
                                            Hydrochloride.                      Disintegrating;   Healthcare
                                                                                Oral.             Pharmaceutical
                                                                                                  s Inc.
NDA 202515.............  MORPHINE SULFATE  Morphine Sulfate  15 mg/mL........  Injectable;       Hospira, A
                                                                                Injection.        Pfizer
                                                                                                  Company.
NDA 203667.............  MINASTRIN 24 FE.  Ethinyl           0.02mg, 1mg.....  Tablet; Oral....  Allergan
                                            Estradiol;                                            Pharmaceutical
                                            Norethindrone                                         s
                                            Acetate.                                              International,
                                                                                                  Ltd.
NDA 210854.............  XOFLUZA.........  Baloxavir         20 mg...........  Tablet; Oral....  Genentech, Inc.
                                            Marboxil.
----------------------------------------------------------------------------------------------------------------

    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: April 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07494 Filed 4-8-24; 8:45 am]
BILLING CODE 4164-01-P