88 FR 93 pgs. 30989-30990 - Determination That CATAPRES (Clonidine Hydrochloride) Tablets, 0.1 Milligrams; 0.2 Milligrams; and 0.3 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Type: NOTICEVolume: 88Number: 93Pages: 30989 - 30990
Pages: 30989, 30990Docket number: [Docket No. FDA-2022-N-1703]
FR document: [FR Doc. 2023-10296 Filed 5-12-23; 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-2022-N-1703]
Determination That CATAPRES (Clonidine Hydrochloride) Tablets, 0.1 Milligrams; 0.2 Milligrams; and 0.3 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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.
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 017407 | CATAPRES | Clonidine Hydrochloride | 0.1 Milligrams (mg); 0.2 mg; 0.3 mg | Tablet; Oral | Boehringer Ingelheim. |
| NDA 017534 | FIORINAL | Aspirin; Butalbital; Caffeine | 325 mg; 50 mg; 40 mg | Capsule; Oral | Allergan Sales. |
| NDA 017876 | LOESTRIN 21 1/20 | Ethinyl Estradiol; Norethindrone Acetate | 0.02 mg; 1 mg | Tablet; Oral | Teva Branded Pharms. |
| NDA 018647 | CORZIDE | Bendroflumethiazide; Nadolol | 5 mg; 40 mg; 5 mg; 80 mg | Tablet; Oral | King Pharms., LLC. |
| NDA 018685 | GAVISCON | Aluminum Hydroxide; Magnesium Trisilicate | 80 mg; 20 mg; 160 mg, 40 mg | Tablet; Oral | Chattem. |
| NDA 018751 | SPECTAZOLE | Econazole Nitrate | 1% | Cream; Topical | Alvogen, Inc. |
| NDA 019813 | DURAGESIC-100 | Fentanyl | 100 Micrograms (mcg)/Hour; 12.5 mcg/Hour; 25 mcg/Hour; 37.5 mcg/Hour; 50 mcg/Hour; 75 mcg/Hour | Film, Extended Release; Transdermal | Janssen Pharms. |
| NDA 020519 | CICLOPIROX | Ciclopirox | 0.77% | Gel; Topical | Alvogen, Inc. |
| NDA 021015 | ANDROGEL | Testosterone | 25 mg/2.5 Grams (g) Packet; 50 mg/5 g Packet | Gel; Transdermal | Besins Healthcare. |
| NDA 021152 | CUTIVATE | Fluticasone Propionate | 0.05% | Lotion; Topical | Fougera Pharms. |
| NDA 021169 | RAZADYNE | Galantamine Hydrobromide | Equivalent to (EQ) 4 mg Base; EQ 8 mg Base; EQ 12 mg Base | Tablet; Oral | Janssen Pharms. |
| NDA 021567 | REYATAZ | Atazanavir Sulfate | EQ 150 mg Base | Capsule; Oral | Bristol Myers Squibb. |
| NDA 021695 | ANTARA (MICRONIZED) | Fenofibrate | 30 mg | Capsule; Oral | Lupin. |
| NDA 022107 | TEKTURNA HCT | Aliskiren Hemifumarate; Hydrochlorothiazide | EQ 150 mg Base; 12.5 mg; EQ 150 mg Base; 25 mg; 300 mg; 12.5 mg; 300 mg; 25 mg | Tablet; Oral | Noden Pharma. |
| NDA 022309 | ANDROGEL | Testosterone | 1.62% (20.25 mg/1.25 g Packet); 1.62% (40.5 mg/2.5 g Packet) | Gel; Transdermal | Besins Healthcare. |
| NDA 022401 | TWYNSTA | Amlodipine Besylate; Telmisartan | EQ 5 mg Base; 40 mg; EQ 10 mg Base; 40 mg; EQ 5 mg Base; 80 mg; EQ 10 mg Base; 80 mg | Tablet; Oral | Boehringer Ingelheim. |
| NDA 022426 | OSENI | Alogliptin Benzoate; Pioglitazone Hydrochloride | EQ 12.5 mg Base; EQ 15 mg Base; EQ 12.5 mg Base; EQ 45 mg Base | Tablet; Oral | Takeda Pharms. USA. |
| NDA 050824 | OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN | Amoxicillin; Clarithromycin; Omeprazole | 500 mg, n/a, n/a; n/a, 500 mg, n/a; n/a, n/a, 20 mg | Capsule, Tablet, Capsule, Delayed Release; Oral | Cumberland Pharms. |
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: May 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10296 Filed 5-12-23; 8:45 am]
BILLING CODE 4164-01-P