88 FR 24 pgs. 7736-7738 - 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That TRIAMCINOLONE ACETONIDE (Triamcinolone Acetonide) Topical Cream, 0.025% and 0.1%, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Type: NOTICEVolume: 88Number: 24Pages: 7736 - 7738
Pages: 7736, 7737, 7738Docket number: [Docket No. FDA-2023-N-0218]
FR document: [FR Doc. 2023-02442 Filed 2-3-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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That TRIAMCINOLONE ACETONIDE (Triamcinolone Acetonide) Topical Cream, 0.025% and 0.1%, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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.
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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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, Stacy.Kane@fda.hhs.gov.
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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 §?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.
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| Application No. | Drug name | Active ingredient(s) | Strength(s) | Dosage form/route | Applicant |
|---|---|---|---|---|---|
| NDA 011601 | TRIAMCINOLONE ACETONIDE | Triamcinolone Acetonide | 0.025%; 0.1% | Cream; Topical | Mylan. |
| NDA 012575 | ACTIFED W/CODEINE | Codeine Phosphate; Pseudoephedrine Hydrochloride; Triprolidine Hydrochloride | 10 Milligrams (mg)/5 Milliliters (mL); 30 mg5 mL; 1.25 mg/5 mL | Syrup; Oral | GlaxoSmithKline. |
| NDA 016267 | DESFERAL | Deferoxamine Mesylate | 2 Grams (g)/Vial | Injectable; Injection | Novartis. |
| NDA 017922 | DDAVP (NEEDS NO REFRIGERATION) | Desmopressin Acetate | 0.01 mg/Spray | Spray, Metered; Nasal | Ferring Pharms., Inc. |
| NDA 018279 | K-TAB | Potassium Chloride | 8 Milliequivalents | Tablet, Extended Release; Oral | Abbvie. |
| NDA 018830 | TAMBOCOR | Flecainide Acetate | 200 mg | Tablet; Oral | Alvogen. |
| NDA 018983 | COLYTE | Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous | 227.1 g/Packet, 2.82 g/Packet, 6.36 g/Packet, 5.53 g/Packet, 21.5 g/Packet; 120 g/Packet, 1.49 g/Packet, 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 | For Solution; Oral | Mylan Specialty, L.P. |
| NDA 019641 | TERAZOL 3 | Terconazole | 80 mg | Suppository; Vaginal | Janssen Pharms. |
| NDA 019821 | SORIATANE | Acitretin | 10 mg; 17.5 mg; 22.5 mg; 25 mg | Capsule; Oral | Stiefel Labs, Inc. |
| NDA 019898 | PRAVACHOL | Pravastatin Sodium | 20 mg; 40 mg; 80 mg | Tablet; Oral | Bristol Myers Squibb Co. |
| NDA 019963 | RENOVA | Tretinoin | 0.05% | Cream; Topical | Valeant. |
| NDA 020103 | ZOFRAN | Ondansetron Hydrochloride | Equivalent to (EQ) 4 mg Base; EQ 8 mg Base; EQ 24 mg Base | Tablet; Oral | Novartis. |
| NDA 020114 | ASTELIN | Azelastine Hydrochloride | 0.137 mg/Spray | Spray, Metered; Nasal | Mylan Specialty. |
| NDA 020130 | ESTROSTEP FE | Ethinyl Estradiol; Norethindrone Acetate | 0.02 mg, 0.03 mg, 0.035 mg; 1 mg, 1 mg, 1 mg | Tablet; Oral-28 | Apil. |
| NDA 020279 | DERMATOP E EMOLLIENT | Prednicarbate | 0.1% | Cream; Topical | Valeant Bermuda. |
| NDA 020408 | TRUSOPT | Dorzolamide Hydrochloride | EQ 2% Base | Solution/Drops; Ophthalmic | Merck. |
| NDA 020658 | REQUIP | Ropinirole Hydrochloride | EQ 0.25 mg Base; EQ 0.5 mg Base; EQ 1; EQ 2 mg Base; EQ 3 mg Base; EQ 4 mg Base; EQ 5 mg Base | Tablet; Oral | GlaxoSmithKline. |
| NDA 020667 | MIRAPEX | Pramipexole Dihydrochloride | 0.125 mg; 0.25 mg; 0.5 mg; 0.75 mg; 1 mg; 1.5 mg | Tablet; Oral | Boehringer Ingelheim. |
| NDA 020793 | CAFCIT | Caffeine Citrate | EQ 30 mg Base/3 mL | Solution; Oral | Hikma. |
| NDA 021076 | ALEVE-D SINUS & COLD | Naproxen Sodium; Pseudoephedrine Hydrochloride | 220 mg, 120 mg | Tablet, Extended Release; Oral | Bayer. |
| NDA 021158 | FACTIVE | Gemifloxacin Mesylate | EQ 320 mg Base | Tablet; Oral | LG Chem. Ltd. |
| NDA 021513 | ENABLEX | Darifenacin Hydrobromide | EQ 7.5 mg Base; EQ 15 mg Base | Tablet, Extended Release; Oral | Apil. |
| NDA 021611 | OPANA | Oxymorphone Hydrochloride | 5 mg; 10 mg | Tablet; Oral | Endo Pharms. |
| NDA 021842 | ACTOPLUS MET | Metformin Hydrochloride; Pioglitazone Hydrochloride | 500 mg; EQ 15 mg Base | Tablet; Oral | Takeda Pharms. USA. |
| NDA 022203 | ASTEPRO | Azelastine Hydrochloride | 0.137 mg/Spray | Spray, Metered; Nasal | Mylan Specialty. |
| NDA 022434 | ARGATROBAN IN SODIUM CHLORIDE | Argatroban | 50 mg/50 mL | Injectable; Intravenous | Eagle Pharms. |
| NDA 050537 | CLEOCIN T | Clindamycin Phosphate | EQ 1% Base | Solution; Topical | Pfizer. |
| NDA 050580 | AZACTAM | Aztreonam | 500 mg/Vial | Injectable; Injection | Bristol Myers Squibb. |
| NDA 204031 | XARTEMIS XR | Acetaminophen; Oxycodone Hydrochloride | 325 mg; 7.5 mg | Tablet, Extended Release; Oral | Mallinckrodt, Inc. |
| NDA 209481 | VANCOMYCIN HYDROCHLORIDE | Vancomycin Hydrochloride | EQ 250 mg Base/Vial | Powder; Intravenous | Mylan Labs Ltd. |
| NDA 209905 | EVEKEO ODT | Amphetamine Sulfate | 2.5 mg | Tablet, Orally Disintegrating; Oral | Azurity. |
FDA has reviewed its records and, under §?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