[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43388-43390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19611]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-4758]
Determination That CORTONE (Cortisone Acetate) Tablets and Other
Drug Products Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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withdrawn from sale for reasons of safety or effectiveness.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].
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
[[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 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.
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Active Dosage form/
Application No. Drug name ingredient(s) Strength(s) route Applicant
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NDA 007750............ CORTONE......... Cortisone 25 milligrams Tablet; Oral.... Merck & Co.,
Acetate. (mg). Inc.
NDA 008662............ NYDRAZID........ Isoniazid....... 100 mg/ Injectable; Sandoz Canada
milliliter (mL). Injection. Inc.
NDA 010571............ COMPAZINE....... Prochlorperazine Equivalent to Tablet; Oral.... SmithKline
Maleate. (EQ) 5 mg Base; Beecham
EQ 10 mg Base; Corporation d/b/
EQ 25 mg Base. 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 Suppository; SmithKline
mg. Rectal. Beecham
Corporation d/b/
a
GlaxoSmithKline
.
NDA 011808............ MELLARIL........ Thioridazine 30 mg/mL; 100 mg/ Concentrate; Novartis
Hydrochloride mL. Oral. Pharmaceuticals
(HCl). 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; Perphenazine; 2 mg/10 mg; 2 mg/ Tablet; Oral.... Schering Corp.
ETRAFON 2-25; Amitriptyline 25 mg; 4 mg/10
ETRAFON-A; HCl. mg; 4 mg/25 mg.
ETRAFON-FORTE.
NDA 014715............ TRIAVIL 2-10; Perphenazine; 2 mg/10 mg; 2 mg/ Tablet; Oral.... New River
TRIAVIL 2-25; Amitriptyline 25 mg; 4 mg/10 Pharmaceuticals
TRIAVIL 4-10; HCl. mg; 4 mg/25 mg; Inc.
TRIAVIL 4-25; 4 mg/50 mg.
TRIAVIL 4-50.
NDA 015539............ SERAX........... Oxazepam........ 10 mg; 15 mg; 30 Capsule; Oral... Alpharma U.S.
mg; 15 mg. Tablet; Oral.... Pharmaceuticals
Division.
NDA 015922............ HALDOL.......... Haloperidol EQ 2 mg Base/mL. Concentrate; Ortho-McNeil
Lactate. Oral. Pharmaceutical.
NDA 016584............ NAVANE.......... Thiothixene..... 1 mg; 2 mg; 5 Capsule; Oral... Pfizer Inc.
mg; 10 mg; 20
mg.
NDA 016721............ DALMANE......... Flurazepam HCl.. 15 mg; 30 mg.... Capsule; Oral... Valeant
Pharmaceuticals
International.
NDA 017923............ MELLARIL-S...... Thioridazine.... EQ 25 mg HCl/5 Suspension; Oral Novartis
mL; EQ 100 mg Pharmaceuticals
HCl/5mL. Corp.
NDA 018374............ BACTRIM......... Sulfamethoxazole 80 mg/mL; 16 mg/ Injectable; Sun
; Trimethoprim. mL. Injection. Pharmaceutical
Industries,
Inc.
NDA 018485............ ISOPTIN......... Verapamil HCl... 2.5 mg/mL....... Injectable; Mt. Adams
Injection. Technologies
LLC.
NDA 018596............ INTAL........... Cromolyn Sodium. 10 mg/mL........ Solution; King
Inhalation. Pharmaceuticals
LLC.
NDA 018644............ WELLBUTRIN...... Bupropion HCl... 50 mg; 75 mg; Tablet; Oral.... GlaxoSmithKline
100 mg. LLC.
NDA 019287............ DIZAC........... Diazepam........ 5 mg/mL......... Injectable; Pharmacia and
Injection. Upjohn Co.
NDA 019982............ ZEBETA.......... Bisoprolol 5 mg; 10 mg..... Tablet; Oral.... Teva Branded
Fumarate. Pharmaceutical
Products R&D,
Inc.
NDA 020007............ ZOFRAN; ZOFRAN Ondansetron HCl. EQ 2 mg Base/mL. Injectable; Novartis
PRESERVATIVE Injection. Pharmaceuticals
FREE. Corp.
NDA 020205............ PSORCON......... Diflorasone 0.05%........... Cream; Topical.. Taro
Diacetate. Pharmaceuticals
North America
Inc.
NDA 020947............ PENNSAID........ Diclofenac 1.5%............ Solution; Nuvo
Sodium. Topical. Pharmaceuticals
Inc.
NDA 021575............ FOSAMAX......... Alendronate EQ 70 mg Base/75 Solution; Oral.. Merck Sharp &
Sodium. mL. Dohme Corp., a
subsidiary of
Merck & Co.,
Inc.
NDA 050542............ AMOXIL.......... Amoxicillin..... 125 mg; 250 mg.. Chewable Tablet; Dr. Reddy's
Oral. Laboratories,
Inc.
NDA 050564............ AUGMENTIN `250'; Amoxicillin; 250 mg/EQ 125 mg Tablet; Oral.... Do.
AUGMENTIN `500`. Clavulanate Base; 500 mg/EQ
Potassium. 125 mg Base.
NDA 050581............ MEFOXIN IN Cefoxitin Sodium EQ 20 mg Base/ Injectable; Merck & Co.,
SODIUM CHLORIDE mL; EQ 40 mg Injection. Inc.
0.9% IN PLASTIC Base/mL; EQ 20
CONTAINER; mg Base/mL; EQ
MEFOXIN IN 40 mg Base/mL.
DEXTROSE 5% IN
PLASTIC
CONTAINER.
NDA 050591............ BACTROBAN....... Mupirocin....... 2%.............. Ointment; SmithKline
Topical. 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 For Suspension; Do.
mg/5 mL. Oral.
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[[Page 43390]]
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 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