[Federal Register Volume 87, Number 152 (Tuesday, August 9, 2022)]
[Notices]
[Pages 48484-48486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17056]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1694]


Determination That AVC (Sulfanilamide) Vaginal Cream, 15%, 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Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety 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withdrawn from sale for reasons of safety or effectiveness.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.

[[Page 48485]]



----------------------------------------------------------------------------------------------------------------
                                             Active
  Application No.       Drug name        ingredient(s)       Strength(s)     Dosage form/route      Applicant
----------------------------------------------------------------------------------------------------------------
NDA 006530........  AVC..............  Sulfanilamide....  15%..............  Cream; Vaginal...  Mylan Specialty
                                                                                                 LP.
NDA 007936........  SELSUN...........  Selenium Sulfide.  2.5%.............  Lotion/Shampoo;    Chattem, Inc.
                                                                              Topical.
NDA 008816........  XYLOCAINE........  Lidocaine          2%...............  Jelly; Topical...  Akorn.
                                        Hydrochloride.
NDA 009218........  COUMADIN.........  Warfarin Sodium..  1 Milligram (mg).  Tablet; Oral.....  Bristol Myers
                                                                                                 Squibb.
NDA 012806........  CORDRAN SP.......  Flurandrenolide..  0.025%...........  Cream; Topical...  Almirall.
NDA 016647........  QUINAGLUTE.......  Quinidine          324 mg...........  Tablet, Extended   Bayer
                                        Gluconate.                            Release; Oral.     Healthcare.
NDA 017386........  ZAROXOLYN........  Metolazone.......  2.5 mg; 5 mg; 10   Tablet; Oral.....  Lannett Co.,
                                                           mg.                                   Inc.
NDA 017531........  TIGAN............  Trimethobenzamide  300 mg...........  Capsule; Oral....  King Pharms LLC.
                                        Hydrochloride.
NDA 018081........  DEPAKENE.........  Valproic Acid....  250 mg...........  Capsule; Oral....  AbbVie Inc.
NDA 018281........  TEGRETOL.........  Carbamazepine....  100 mg...........  Tablet, Chewable;  Novartis.
                                                                              Oral.
NDA 018303........  LOPRESSOR HCT....  Hydrochlorothiazi  25mg; 100mg......  Tablet; Oral.....  Validus Pharms.
                                        de; Metoprolol
                                        Tartrate.
NDA 018878........  INDOCIN..........  Indomethacin       EQ 1 mg Base/Vial  Injectable;        Recordati Rare
                                        Sodium.                               Injection.         Diseases.
NDA 019404........  OCUFEN...........  Flurbiprofen       0.03%............  Solution/Drops;    Allergan.
                                        Sodium.                               Ophthalmic.
NDA 019661........  CYTOVENE.........  Ganciclovir        EQ 500 mg Base/    Injectable;        Cheplapharm.
                                        Sodium.            Vial.              Injection.
NDA 019697........  ORTHO TRI-CYCLEN.  Ethinyl            0.035 mg, 0.035    Tablet; Oral.....  Janssen Pharms.
                                        Estradiol;         mg, 0.035 mg;
                                        Norgestimate.      0.18 mg, 0.215
                                                           mg, 0.25 mg.
NDA 019766........  ZOCOR............  Simvastatin......  80 mg............  Tablet; Oral.....  Organon.
NDA 019814........  BETAGAN..........  Levobunolol        0.25%............  Solution/Drops;    Allergan.
                                        Hydrochloride.                        Ophthalmic.
NDA 019856........  SINEMET CR.......  Carbidopa;         25 mg, 100 mg; 50  Tablet, Extended   Organon.
                                        Levodopa.          mg, 200 mg.        Release; Oral.
NDA 019907........  OPTIPRANOLOL.....  Metipranolol       0.3%.............  Solution/Drops;    Bausch and Lomb.
                                        Hydrochloride.                        Ophthalmic.
NDA 019968........  ULTRAVATE........  Halobetasol        0.05%............  Ointment; Topical  Sun Pharm Inds.
                                        Propionate.                                              Inc.
NDA 020010........  LOTRISONE........  Betamethasone      EQ 0.05% Base; 1%  Lotion; Topical..  Merck Sharp
                                        Dipropionate;                                            Dohme.
                                        Clotrimazole.
NDA 020381........  NIASPAN..........  Niacin...........  500 mg; 750 mg;    Tablet, Extended   AbbVie Inc.
                                                           1g.                Release; Oral.
NDA 020412........  ZERIT............  Stavudine........  15 mg; 20 mg; 30   Capsule; Oral....  Bristol Myers
                                                           mg; 40 mg.                            Squibb.
NDA 020509........  GEMZAR...........  Gemcitabine        EQ 200 mg Base/    Injectable;        Lilly.
                                        Hydrochloride.     Vial; 1 Gram (g)   Injection.
                                                           Base/Vial.
NDA 020593........  DEPACON..........  Valproate Sodium.  100 mg Base/       Injectable;        AbbVie Inc.
                                                           Milliliter (mL).   Injection.
NDA 020615........  DURACLON.........  Clonidine          5 mg/10 mL (0.5    Injectable;        Mylan
                                        Hydrochloride.     mg/mL).            Injection.         Institutional.
NDA 020718........  INTEGRILIN.......  Eptifibatide.....  2 mg/mL; 75 mg/    Injectable;        Merck Sharp
                                                           100 mL.            Injection.         Dohme.
NDA 021005........  SOLARAZE.........  Diclofenac Sodium  3%...............  Gel; Topical.....  Fougera Pharms.
NDA 021085........  AVELOX...........  Moxifloxacin       EQ 400 mg Base...  Tablet; Oral.....  Bayer
                                        Hydrochloride.                                           Healthcare.
NDA 021183........  VIDEX EC.........  Didanosine.......  125 mg; 200 mg;    Capsule, Delayed   Bristol Myers
                                                           250 mg; 400 mg.    Release Pellets;   Squibb.
                                                                              Oral.
NDA 021241........  ORTHO TRI-CYCLEN   Ethinyl            0.025 mg, 0.025    Tablet; Oral-28..  Janssen Pharms.
                     LO.                Estradiol;         mg, 0.025 mg;
                                        Norgestimate.      0.18 mg, 0.215
                                                           mg, 0.25 mg.
NDA 021300........  CLARINEX.........  Desloratadine....  0.5 mg/mL........  Solution; Oral...  Merck Sharp
                                                                                                 Dohme.
NDA 021312........  CLARINEX.........  Desloratadine....  2.5 mg; 5 mg.....  Tablet, Orally     Organon.
                                                                              Disintegrating;
                                                                              Oral.
NDA 021372........  ALOXI............  Palonosetron       EQ 0.25 mg Base/5  Injectable;        Helsinn
                                        Hydrochloride.     mL (EQ 0.05 mg     Intravenous.       Healthcare.
                                                           Base/mL); EQ
                                                           0.075 mg Base/
                                                           1.5 mL (EQ 0.05
                                                           mg Base/mL).
NDA 021444........  RISPERDAL........  Risperidone......  0.5 mg; 1 mg; 2    Tablet, Orally     Janssen Pharms.
                                                           mg; 3 mg; 4 mg.    Disintegrating;
                                                                              Oral.
NDA 021455........  BONIVA...........  Ibandronate        EQ 150 mg Base...  Tablet; Oral.....  Hoffmann La
                                        Sodium.                                                  Roche.
NDA 021605........  CLARINEX D 24      Desloratadine;     5 mg; 240 mg.....  Tablet, Extended   Organon.
                     HOUR.              Pseudoephedrine                       Release; Oral.
                                        Sulfate.
NDA 021858........  BONIVA...........  Ibandronate        EQ 3 mg Base/3 mL  Injectable;        Hoffmann La
                                        Sodium.                               Intravenous.       Roche.
NDA 021860........  SARAFEM..........  Fluoxetine         EQ 10 mg Base; EQ  Tablet; Oral.....  Allergan.
                                        Hydrochloride.     20 mg Base.
NDA 021956........  DUTOPROL.........  Hydrochlorothiazi  12.5 mg; EQ 25 mg  Tablet, Extended   Concordia.
                                        de; Metoprolol     Tartrate; 12.5     Release; Oral.
                                        Succinate.         mg: EQ 50 mg
                                                           Tartrate; 12.5
                                                           mg; EQ 100 mg
                                                           Tartrate.
NDA 022064........  XYZAL............  Levocetirizine     5 mg.............  Tablet; Oral.....  Chattem Sanofi.
                                        Dihydrochloride.
NDA 022106........  DORIBAX..........  Doripenem........  250 mg/Vial; 500   Injectable;        Shionogi, Inc.
                                                           mg/Vial.           Intravenous
                                                                              Infusion.
NDA 022129........  ULESFIA..........  Benzyl Alcohol...  5%...............  Lotion; Topical..  Shionogi, Inc.
NDA 022157........  XYZAL............  Levocetirizine     2.5 mg/5 mL......  Solution; Oral...  Chattem Sanofi.
                                        Dihydrochloride.
NDA 022321........  EMBEDA...........  Morphine Sulfate;  20 mg, 0.8 mg; 30  Capsule, Extended  Alpharma Pharms.
                                        Naltrexone         mg, 1.2 mg; 50     Release; Oral.
                                        Hydrochloride.     mg, 2 mg; 60 mg,
                                                           2.4 mg; 80 mg,
                                                           3.2 mg; 100 mg,
                                                           4 mg.
NDA 050261........  DECLOMYCIN.......  Demeclocycline     75 mg; 150 mg;     Tablet; Oral.....  Corepharma.
                                        Hydrochloride.     300 mg.
NDA 050405........  KEFLEX...........  Cephalexin.......  EQ 250 mg Base;    Capsule; Oral....  Pragma.
                                                           EQ 500 mg Base;
                                                           EQ 750 mg Base.
NDA 050529........  PEDIAZOLE........  Erythromycin       EQ 200 mg Base/5   Granule; Oral....  Ross Labs.
                                        Ethylsuccinate;    mL; EQ 600 mg
                                        Sulfisoxazole      Base/5 mL.
                                        Acetyl.

[[Page 48486]]

 
ANDA 083082.......  CHLOROQUINE        Chloroquine        250 mg; 500 mg...  Tablet; Oral.....  Hikma Pharms.
                     PHOSPHATE.         Phosphate.
NDA 204592........  ZORVOLEX.........  Diclofenac.......  18 mg............  Capsule; Oral....  Zyla.
----------------------------------------------------------------------------------------------------------------

    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: August 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17056 Filed 8-8-22; 8:45 am]
BILLING CODE 4164-01-P


