85 FR 204 pgs. 66994-66995 - Determination That BUTISOL SODIUM (Butabarbital Sodium) Oral Tablets, 15 Milligrams, 50 Milligrams, and 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Type: NOTICEVolume: 85Number: 204Pages: 66994 - 66995
Pages: 66994, 66995Docket number: [Docket No. FDA-2020-N-2032]
FR document: [FR Doc. 2020-23300 Filed 10-20-20; 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-2020-N-2032]
Determination That BUTISOL SODIUM (Butabarbital Sodium) Oral Tablets, 15 Milligrams, 50 Milligrams, and 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 if 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:
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the "listed drug," which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 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 000793 | BUTISOL SODIUM | Butabarbital Sodium | 15 mg; 50 mg; 100 mg | Tablet; Oral | Mylan Specialty, L.P. |
| NDA 007392 | SECONAL SODIUM | Secobarbital Sodium | 50 mg/Milliliter (mL) | Injectable; Injection | Eli Lilly and Co. |
| NDA 012665 | VELBAN | Vinblastine Sulfate | 10 mg/Vial | Injectable; Injection | Eli Lilly and Co. |
| NDA 017015 | PAVULON | Pancuronium Bromide | 1 mg/mL; 2 mg/mL | Injectable; Injection | Schering-Plough Corp. |
| NDA 017919 | ORTHO-NOVUM 1/35-28 | Ethinyl Estradiol; Norethindrone | 0.035 mg;1 mg | Tablet; Oral-28 | Janssen Pharmaceuticals, Inc. |
| NDA 018554 | EULEXIN | Flutamide | 125 mg | Capsule; Oral | Schering-Plough Corp. |
| NDA 019151 | RYTHMOL | Propafenone Hydrochloride | 150 mg, 225 mg, 300 mg | Tablet; Oral | GlaxoSmithKline. |
| NDA 019579 | TERAZOL 7 | Terconazole | 0.4% | Cream; Vaginal | Janssen Pharmaceuticals, Inc. |
| NDA 019599 | NAFTIN | Naftifine Hydrochloride | 1% | Cream; Topical | Sebela Ireland Limited. |
| NDA 019653 | ORTHO CYCLEN-28 | Ethinyl Estradiol; Norgestimate | 0.035 mg; 0.25 mg | Tablet; Oral-28 | Janssen Pharmaceuticals, Inc. |
| NDA 019716 | DIPROLENE | Betamethasone Dipropionate | EQ 0.05% Base | Lotion, Augmented; Topical | Merck Sharp & Dohme Corp. |
| NDA 019964 | TERAZOL 3 | Terconazole | 0.8% | Cream; Vaginal | Janssen Pharmaceuticals, Inc. |
| NDA 020313 | MIACALCIN | Calcitonin Salmon | 200 International Units/Spray | Metered Spray; Nasal | Mylan Ireland Limited. |
| NDA 020388 | NAVELBINE | Vinorelbine Tartrate | EQ 10 mg Base/mL | Injectable; Injection | Pierre Fabre Medicament. |
| NDA 020413 | ZERIT | Stavudine | 1 mg/mL | For Solution; Oral | Bristol-Myers Squibb. |
| NDA 020741 | PRANDIN | Repaglinide | 0.5 mg; 1 mg; 2 mg | Tablet; Oral | Gemini Laboratories, LLC. |
| NDA 020872 | CHILDREN'S ALLEGRA ALLERGY | Fexofenadine Hydrochloride | 30 mg | Tablet; Oral | Sanofi-Aventis U.S., LLC. |
| NDA 021071 | AVANDIA | Rosiglitazone Maleate | EQ 8 mg Base | Tablets; Oral | SB Pharmco Puerto Rico, Inc. |
| NDA 021235 | PROZAC WEEKLY | Fluoxetine Hydrochloride | EQ 90 mg/Base | Delayed-Release Capsules; Oral | Eli Lilly and Co. |
| NDA 021909 | CHILDREN'S ALLEGRA HIVES | Fexofenadine Hydrochloride | 30 mg | Tablet, Orally Disintegrating; Oral | Sanofi-Aventis U.S., LLC. |
| NDA 022246 | METOZOLV ODT | Metoclopramide Hydrochloride | EQ 5 mg Base | Tablet, Orally Disintegrating; Oral | Bausch Health US, LLC. |
| NDA 022291 | PROMACTA | Eltrombopag Olamine | EQ 100 mg Acid | Tablet; Oral | Novartis. |
| NDA 022362 | WELCHOL | Colesevelam Hydrochloride | 1.875 g/Packet | For Suspension; Oral | Daiichi Sankyo. |
| NDA 022396 | DYLOJECT | Diclofenac Sodium | 37.5 mg/mL (37.5 mg/mL) | Solution; Intravenous | Javelin Pharmaceuticals, Inc. |
| NDA 050368 | ILOTYCIN | Erythromycin | 0.5% | Ointment; Ophthalmic | Eli Lilly and Co. |
| NDA 050587 | PRIMAXIN | Cilastatin Sodium; Imipenem | EQ 250 mg Base/Vial; 250 mg/Vial | Powder; Intravenous | Merck & Co., Inc. |
| NDA 201373 | CHILDREN'S ALLEGRA HIVES | Fexofenadine Hydrochloride | 30 mg/5 mL | Suspension; Oral | Sanofi-Aventis U.S., LLC. |
| NDA 208411 | NARCAN | Naloxone Hydrochloride | 2 mg/Spray | Spray, Metered; Nasal | Adapt Pharma. |
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 NDAs and ANDAs listed are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. 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: October 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23300 Filed 10-20-20; 8:45 am]
BILLING CODE 4164-01-P