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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2017-N-4758]
 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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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: 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 
                    ( print page 43389)
                    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of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily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. Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
ApplicantNDA 007750
CORTONE
Cortisone Acetate
25 milligrams (mg)
Tablet; Oral
Merck & Co., Inc.NDA 008662
NYDRAZID
Isoniazid
100 mg/milliliter (mL)
Injectable; Injection
Sandoz Canada Inc.NDA 010571
COMPAZINE
Prochlorperazine Maleate
Equivalent to (EQ) 5 mg Base; EQ 10 mg Base; EQ 25 mg Base
Tablet; Oral
SmithKline Beecham Corporation d/b/a GlaxoSmithKline.NDA 010670
ORINASE
Tolbutamide
250 mg; 500 mg
Tablet; Oral
Pharmacia and Upjohn Co.NDA 011127
COMPAZINE
Prochlorperazine
2.5 mg; 5 mg; 25 mg
Suppository; Rectal
SmithKline Beecham Corporation d/b/a GlaxoSmithKline.NDA 011808
MELLARIL
Thioridazine Hydrochloride (HCl)
30 mg/mL; 100 mg/mL
Concentrate; Oral
Novartis Pharmaceuticals Corp.NDA 012145
PROLIXIN
Fluphenazine HCl
2.5 mg/5 mL
Elixir; Oral
Apothecon Inc., Division of Bristol Myers Squibb.NDA 014713
ETRAFON 2-10; ETRAFON 2-25; ETRAFON-A; ETRAFON-FORTE
Perphenazine; Amitriptyline HCl
2 mg/10 mg; 2 mg/25 mg; 4 mg/10 mg; 4 mg/25 mg
Tablet; Oral
Schering Corp.NDA 014715
TRIAVIL 2-10; TRIAVIL 2-25; TRIAVIL 4-10; TRIAVIL 4-25; TRIAVIL 4-50
Perphenazine; Amitriptyline HCl
2 mg/10 mg; 2 mg/25 mg; 4 mg/10 mg; 4 mg/25 mg; 4 mg/50 mg
Tablet; Oral
New River Pharmaceuticals Inc.NDA 015539
SERAX
Oxazepam
10 mg; 15 mg; 30 mg; 15 mg
Capsule; Oral
                             Tablet; Oral
Alpharma U.S. Pharmaceuticals Division.NDA 015922
HALDOL
Haloperidol Lactate
EQ 2 mg Base/mL
Concentrate; Oral
Ortho-McNeil Pharmaceutical.NDA 016584
NAVANE
Thiothixene
1 mg; 2 mg; 5 mg; 10 mg; 20 mg
Capsule; Oral
Pfizer Inc.NDA 016721
DALMANE
Flurazepam HCl
15 mg; 30 mg
Capsule; Oral
Valeant Pharmaceuticals International.NDA 017923
MELLARIL-S
Thioridazine
EQ 25 mg HCl/5 mL; EQ 100 mg HCl/5mL
Suspension; Oral
Novartis Pharmaceuticals Corp.NDA 018374
BACTRIM
Sulfamethoxazole; Trimethoprim
80 mg/mL; 16 mg/mL
Injectable; Injection
Sun Pharmaceutical Industries, Inc.NDA 018485
ISOPTIN
Verapamil HCl
2.5 mg/mL
Injectable; Injection
Mt. Adams Technologies LLC.NDA 018596
INTAL
Cromolyn Sodium
10 mg/mL
Solution; Inhalation
King Pharmaceuticals LLC.NDA 018644
WELLBUTRIN
Bupropion HCl
50 mg; 75 mg; 100 mg
Tablet; Oral
GlaxoSmithKline LLC.NDA 019287
DIZAC
Diazepam
5 mg/mL
Injectable; Injection
Pharmacia and Upjohn Co.NDA 019982
ZEBETA
Bisoprolol Fumarate
5 mg; 10 mg
Tablet; Oral
Teva Branded Pharmaceutical Products R&D, Inc.NDA 020007
ZOFRAN; ZOFRAN PRESERVATIVE FREE
Ondansetron HCl
EQ 2 mg Base/mL
Injectable; Injection
Novartis Pharmaceuticals Corp.NDA 020205
PSORCON
Diflorasone Diacetate
0.05%
Cream; Topical
Taro Pharmaceuticals North America Inc.NDA 020947
PENNSAID
Diclofenac Sodium
1.5%
Solution; Topical
Nuvo Pharmaceuticals Inc.NDA 021575
FOSAMAX
Alendronate Sodium
EQ 70 mg Base/75 mL
Solution; Oral
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NDA 050542
AMOXIL
Amoxicillin
125 mg; 250 mg
Chewable Tablet; Oral
Dr. Reddy's Laboratories, Inc.NDA 050564
AUGMENTIN ‘250’; AUGMENTIN ‘500‘
Amoxicillin; Clavulanate Potassium
250 mg/EQ 125 mg Base; 500 mg/EQ 125 mg Base
Tablet; Oral
Do.NDA 050581
MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER; MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Cefoxitin Sodium
EQ 20 mg Base/mL; EQ 40 mg Base/mL; EQ 20 mg Base/mL; EQ 40 mg Base/mL
Injectable; Injection
Merck & Co., Inc.NDA 050591
BACTROBAN
Mupirocin
2%
Ointment; Topical
SmithKline Beecham (Cork) Ltd., Ireland.NDA 050594
ERYCETTE
Erythromycin
2%
Swab; Topical
Johnson & Johnson Consumer Inc.NDA 050754
AMOXIL
Amoxicillin
500 mg; 875 mg
Tablet; Oral
Dr. Reddy's Laboratories, Inc.NDA 050760
AMOXIL
Amoxicillin
200 mg/5 mL; 400 mg/5 mL
For Suspension; Oral
Do.
 
 
 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: September 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.


[FR Doc. 2017-19611 Filed 9-14-17; 8:45 am] BILLING CODE 4164-01-P