[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]
-----------------------------------------------------------------------
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Not Withdrawn From Sale for Reasons of Safety or Effectiveness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.
-----------------------------------------------------------------------
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withdrawn from sale for reasons of safety or effectiveness.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