[Federal Register Volume 88, Number 24 (Monday, February 6, 2023)]
[Notices]
[Pages 7736-7738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02442]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0218]


Determination That TRIAMCINOLONE ACETONIDE (Triamcinolone 
Acetonide) Topical Cream, 0.025% and 0.1%, 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Not Withdrawn From Sale for Reasons of Safety or Effectiveness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withdrawn from sale for reasons of safety or effectiveness.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].

[[Page 7737]]


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 011601..........  TRIAMCINOLONE      Triamcinolone      0.025%; 0.1%....  Cream; Topical..  Mylan.
                       ACETONIDE.         Acetonide.
NDA 012575..........  ACTIFED W/CODEINE  Codeine            10 Milligrams     Syrup; Oral.....  GlaxoSmithKline.
                                          Phosphate;         (mg)/5
                                          Pseudoephedrine    Milliliters
                                          Hydrochloride;     (mL); 30 mg5
                                          Triprolidine       mL; 1.25 mg/5
                                          Hydrochloride.     mL.
NDA 016267..........  DESFERAL.........  Deferoxamine       2 Grams (g)/Vial  Injectable;       Novartis.
                                          Mesylate.                            Injection.
NDA 017922..........  DDAVP (NEEDS NO    Desmopressin       0.01 mg/Spray...  Spray, Metered;   Ferring Pharms.,
                       REFRIGERATION).    Acetate.                             Nasal.            Inc.
NDA 018279..........  K-TAB............  Potassium          8                 Tablet, Extended  Abbvie.
                                          Chloride.          Milliequivalent   Release; Oral.
                                                             s.
NDA 018830..........  TAMBOCOR.........  Flecainide         200 mg..........  Tablet; Oral....  Alvogen.
                                          Acetate.
NDA 018983..........  COLYTE...........  Polyethylene       227.1 g/Packet,   For Solution;     Mylan Specialty,
                                          Glycol 3350;       2.82 g/Packet,    Oral.             L.P.
                                          Potassium          6.36 g/Packet,
                                          Chloride; Sodium   5.53 g/Packet,
                                          Bicarbonate;       21.5 g/Packet;
                                          Sodium Chloride;   120 g/Packet,
                                          Sodium Sulfate     1.49 g/Packet,
                                          Anhydrous.         3.36 g/Packet,
                                                             2.92g/Packet,
                                                             11.36g/Packet;
                                                             360 g/Packet,
                                                             4.47 g/Packet,
                                                             10.08 g/Packet,
                                                             8.76 g/Packet,
                                                             34.08 g/Packet;
                                                             240 g/Bottle,
                                                             2.98 g/Bottle,
                                                             6.72g/Bottle,
                                                             5.84 g/Bottle,
                                                             22.72 g/Bottle;
                                                             227.1 g/Bottle,
                                                             2.82 g/Bottle,
                                                             6.36g/Bottle,
                                                             5.53 g/Bottle,
                                                             21.5g/Bottle;.
                                                            227.1 g/Bottle,
                                                             2.82 g/Bottle,
                                                             6.36 g/Bottle,
                                                             5.53 g/Bottle,
                                                             21.5 g/Bottle;
                                                             240 g/Bottle,
                                                             2.98 g/Bottle,
                                                             6.72 g/Bottle,
                                                             5.84 g/Bottle,
                                                             22.72 g/Bottle.
NDA 019641..........  TERAZOL 3........  Terconazole......  80 mg...........  Suppository;      Janssen Pharms.
                                                                               Vaginal.
NDA 019821..........  SORIATANE........  Acitretin........  10 mg; 17.5 mg;   Capsule; Oral...  Stiefel Labs,
                                                             22.5 mg; 25 mg.                     Inc.
NDA 019898..........  PRAVACHOL........  Pravastatin        20 mg; 40 mg; 80  Tablet; Oral....  Bristol Myers
                                          Sodium.            mg.                                 Squibb Co.
NDA 019963..........  RENOVA...........  Tretinoin........  0.05%...........  Cream; Topical..  Valeant.
NDA 020103..........  ZOFRAN...........  Ondansetron        Equivalent to     Tablet; Oral....  Novartis.
                                          Hydrochloride.     (EQ) 4 mg Base;
                                                             EQ 8 mg Base;
                                                             EQ 24 mg Base.
NDA 020114..........  ASTELIN..........  Azelastine         0.137 mg/Spray..  Spray, Metered;   Mylan Specialty.
                                          Hydrochloride.                       Nasal.

[[Page 7738]]

 
NDA 020130..........  ESTROSTEP FE.....  Ethinyl            0.02 mg, 0.03     Tablet; Oral-28.  Apil.
                                          Estradiol;         mg, 0.035 mg; 1
                                          Norethindrone      mg, 1 mg, 1 mg.
                                          Acetate.
NDA 020279..........  DERMATOP E         Prednicarbate....  0.1%............  Cream; Topical..  Valeant Bermuda.
                       EMOLLIENT.
NDA 020408..........  TRUSOPT..........  Dorzolamide        EQ 2% Base......  Solution/Drops;   Merck.
                                          Hydrochloride.                       Ophthalmic.
NDA 020658..........  REQUIP...........  Ropinirole         EQ 0.25 mg Base;  Tablet; Oral....  GlaxoSmithKline.
                                          Hydrochloride.     EQ 0.5 mg Base;
                                                             EQ 1; EQ 2 mg
                                                             Base; EQ 3 mg
                                                             Base; EQ 4 mg
                                                             Base; EQ 5 mg
                                                             Base.
NDA 020667..........  MIRAPEX..........  Pramipexole        0.125 mg; 0.25    Tablet; Oral....  Boehringer
                                          Dihydrochloride.   mg; 0.5 mg;                         Ingelheim.
                                                             0.75 mg; 1 mg;
                                                             1.5 mg.
NDA 020793..........  CAFCIT...........  Caffeine Citrate.  EQ 30 mg Base/3   Solution; Oral..  Hikma.
                                                             mL.
NDA 021076..........  ALEVE-D SINUS &    Naproxen Sodium;   220 mg, 120 mg..  Tablet, Extended  Bayer.
                       COLD.              Pseudoephedrine                      Release; Oral.
                                          Hydrochloride.
NDA 021158..........  FACTIVE..........  Gemifloxacin       EQ 320 mg Base..  Tablet; Oral....  LG Chem. Ltd.
                                          Mesylate.
NDA 021513..........  ENABLEX..........  Darifenacin        EQ 7.5 mg Base;   Tablet, Extended  Apil.
                                          Hydrobromide.      EQ 15 mg Base.    Release; Oral.
NDA 021611..........  OPANA............  Oxymorphone        5 mg; 10 mg.....  Tablet; Oral....  Endo Pharms.
                                          Hydrochloride.
NDA 021842..........  ACTOPLUS MET.....  Metformin          500 mg; EQ 15 mg  Tablet; Oral....  Takeda Pharms.
                                          Hydrochloride;     Base.                               USA.
                                          Pioglitazone
                                          Hydrochloride.
NDA 022203..........  ASTEPRO..........  Azelastine         0.137 mg/Spray..  Spray, Metered;   Mylan Specialty.
                                          Hydrochloride.                       Nasal.
NDA 022434..........  ARGATROBAN IN      Argatroban.......  50 mg/50 mL.....  Injectable;       Eagle Pharms.
                       SODIUM CHLORIDE.                                        Intravenous.
NDA 050537..........  CLEOCIN T........  Clindamycin        EQ 1% Base......  Solution;         Pfizer.
                                          Phosphate.                           Topical.
NDA 050580..........  AZACTAM..........  Aztreonam........  500 mg/Vial.....  Injectable;       Bristol Myers
                                                                               Injection.        Squibb.
NDA 204031..........  XARTEMIS XR......  Acetaminophen;     325 mg; 7.5 mg..  Tablet, Extended  Mallinckrodt,
                                          Oxycodone                            Release; Oral.    Inc.
                                          Hydrochloride.
NDA 209481..........  VANCOMYCIN         Vancomycin         EQ 250 mg Base/   Powder;           Mylan Labs Ltd.
                       HYDROCHLORIDE.     Hydrochloride.     Vial.             Intravenous.
NDA 209905..........  EVEKEO ODT.......  Amphetamine        2.5 mg..........  Tablet, Orally    Azurity.
                                          Sulfate.                             Disintegrating;
                                                                               Oral.
----------------------------------------------------------------------------------------------------------------

    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: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02442 Filed 2-3-23; 8:45 am]
BILLING CODE 4164-01-P


