[Federal Register Volume 82, Number 81 (Friday, April 28, 2017)]
[Notices]
[Pages 19735-19737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08582]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1551]
Determination That DEMEROL (Meperidine Hydrochloride) Injectable
and Other Drug Products Were Not Withdrawn From Sale for Reasons of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withdrawn from sale for reasons of safety or effectiveness.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. Through this notice, FDA is hoping to
stimulate the economy and increase the regulatory certainty with
respect to generic versions of these drug products by confirming that
generic versions of the subject drug products may continue to be
marketed.
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 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
[[Page 19736]]
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 in
this document 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 005010............ DEMEROL......... Meperidine 50 milligrams Syrup; Oral..... U.S.
Hydrochloride. (mg)/5 Pharmaceutical
milliliter (mL). Holdings II,
LLC.
NDA 006035............ METHERGINE...... Methylergonovine 0.2 mg.......... Tablet; Oral.... Edison
Maleate. Therapeutics
LLC.
NDA 007337............ PERCODAN and Aspirin, 325 mg, 4.5 mg, Tablet; Oral.... Endo
PERCODAN-DEMI. Oxycodone 0.38 mg; and Pharmaceuticals
Hydrochloride, 325 mg, 2.25 Inc.
Oxycodone mg, 0.19 mg.
Terephthalate.
NDA 008720............ LEVO-DROMORAN... Levorphanol 2 mg............ Tablet; Oral.... Valeant
Tartrate. Pharmaceuticals
North America
LLC.
NDA 008848............ PAMINE and Methscopolamine 2.5 mg and 5 mg. Tablet; Oral.... Fougera
PAMINE FORTE. Bromide. Pharmaceuticals
Inc.
NDA 009470............ XYLOCAINE Lidocaine 2%.............. Solution; Oral.. Fresenius Kabi
VISCOUS. Hydrochloride. USA, LLC.
NDA 010485............ ATARAX.......... Hydroxyzine 10 mg/5 mL...... Syrup; Oral..... Pfizer Inc.
Hydrochloride.
NDA 010742............ COMPAZINE....... Prochlorperazine Equivalent to Injectable; GlaxoSmithKline.
Edisylate. (EQ) 5 mg Base/ Injection.
mL.
NDA 012111............ MYDRIACYL....... Tropicamide..... 0.5%; 1%........ Solution/Drops; Alcon
Ophthalmic. Laboratories
Inc.
NDA 012248............ PLEGINE......... Phendimetrazine 35 mg........... Tablet; Oral.... Wyeth Ayerst
Tartrate. Laboratories.
NDA 012365............ SOMA COMPOUND... Aspirin; 325 mg; 200 mg.. Tablet; Oral.... Meda
Carisoprodol. Pharmaceuticals
Inc.
NDA 012366............ SOMA COMPOUND W/ Aspirin; 325 mg; 200 mg; Tablet; Oral.... Ditto.
CODEINE. Carisoprodol; 16 mg.
Codeine
Phosphate.
NDA 016012............ VIVACTIL........ Protriptyline 5 mg; 10 mg..... Tablet; Oral.... Teva Women's
Hydrochloride. Health, Inc.
NDA 017352............ FASTIN.......... Phentermine 30 mg........... Capsule; Oral... GlaxoSmithKline.
Hydrochloride.
NDA 017690............ IMODIUM......... Loperamide 2 mg............ Capsule; Oral... Johnson &
Hydrochloride. Johnson
Consumer Inc.
NDA 017694............ IMODIUM......... Loperamide 2 mg............ Capsule; Oral... Ditto.
Hydrochloride.
NDA 017741............ FLORONE......... Diflorasone 0.05%........... Cream; Topical.. Pharmacia and
Diacetate. Upjohn Co.
NDA 017802............ LO/OVRAL-28..... Ethinyl 0.03 mg; 0.3 mg. Tablet; Oral-28. Wyeth
Estradiol; Pharmaceuticals
Norgestrel. Inc.
NDA 017857............ STADOL.......... Butorphanol 2 mg/mL......... Injectable; Delcor Asset
Tartrate. Injection. Corporation.
NDA 017857............ STADOL Butorphanol 1 mg/mL; 2 mg/mL Injectable; Ditto.
PRESERVATIVE Tartrate. Injection.
FREE.
NDA 018342............ WELLCOVORIN..... Leucovorin EQ 5 mg Base; EQ Tablet; Oral.... GlaxoSmithKline.
Calcium. 25 mg Base.
NDA 018353............ FLAGYL I.V...... Metronidazole EQ 500 mg Base/ Injectable; G.D. Searle LLC,
Hydrochloride. Vial. Injection. a subsidiary of
Pfizer Inc.
NDA 018733............ TALWIN NX....... Naloxone EQ 0.5 mg Base; Tablet; Oral.... Sanofi-Aventis
Hydrochloride; EQ 50 mg Base. U.S. LLC.
Pentazocine
Hydrochloride.
NDA 019488............ CARDENE......... Nicardipine 20 mg; 30 mg.... Capsule; Oral... Chiesi USA, Inc.
Hydrochloride.
NDA 019578............ MEFLOQUINE Mefloquine 250 mg.......... Tablet; Oral.... U.S. Army Walter
HYDROCHLORIDE. Hydrochloride. Reed Army
Institute
Research.
NDA 019591............ LARIAM.......... Mefloquine 250 mg.......... Tablet; Oral.... Hoffmann-La
Hydrochloride. Roche Inc.
NDA 019735............ FLOXIN.......... Ofloxacin....... 200 mg; 300 mg; Tablet; Oral.... Janssen
400 mg. Pharmaceuticals
, Inc.
NDA 019890............ STADOL.......... Butorphanol 1 mg/Spray...... Spray, Metered; Bristol-Myers
Tartrate. Nasal. Squibb Co.
NDA 020142............ CATAFLAM........ Diclofenac 50 mg........... Tablet; Oral.... Novartis
Potassium. Pharmaceuticals
Corp.
NDA 020254............ VOLTAREN-XR..... Diclofenac 100 mg.......... Extended-Release Ditto.
Sodium. Tablet; Oral.
NDA 020312............ UNIVASC......... Moexipril 7.5 mg; 15 mg... Tablet; Oral.... UCB, Inc.
Hydrochloride.
NDA 020346............ ZYRTEC.......... Cetirizine 5 mg/5 mL....... Syrup; Oral..... Johnson &
Hydrochloride. Johnson
Consumer Inc.
NDA 020584............ LODINE XL....... Etodolac........ 400 mg; 500 mg; Extended-Release Wyeth
600 mg. Tablet; Oral. Pharmaceuticals
Inc.
NDA 020625............ ALLEGRA......... Fexofenadine 60 mg........... Capsule; Oral... Sanofi-Aventis
Hydrochloride. U.S. LLC.
NDA 020729............ UNIRETIC........ Hydro 12.5 mg/7.5 mg; Tablet; Oral.... UCB, Inc.
chlorothiazide; 12.5 mg/15 mg;
Moexipril 25 mg/15 mg.
Hydrochloride.
NDA 021066............ ZADITOR......... Ketotifen EQ 0.025% Base.. Solution/Drops; Alcon
Fumarate. Ophthalmic. Pharmaceuticals
, Ltd.
NDA 021224............ RAZADYNE........ Galantamine 4 mg/mL......... Solution; Oral.. Janssen
Hydrobromide. Pharmaceuticals
, Inc.
NDA 021378............ COMBUNOX........ Ibuprofen; 400 mg; 5 mg.... Tablet; Oral.... Forest
Oxycodone Laboratories,
Hydrochloride. Inc.
NDA 021473............ CIPRO XR........ Ciprofloxacin; 212.6 mg; EQ Extended-Release Bayer HealthCare
Ciprofloxacin 287.5 mg Base; Tablet; Oral. Pharmaceuticals
Hydrochloride. 425.2 mg; EQ , Inc.
574.9 mg Base.
NDA 021606............ ZEMPLAR......... Paricalcitol.... 4 micrograms Capsule; Oral... AbbVie Inc.
(mcg).
NDA 021729............ ABILIFY......... Aripiprazole.... 10 mg and 15 mg. Tablet, Orally Otsuka
Disintegrating; Pharmaceutical
Oral. Co., Ltd.
[[Page 19737]]
NDA 050072............ PENBRITIN-S..... Ampicillin EQ 125 mg Base/ Injectable; Wyeth Ayerst
Sodium. Vial; EQ 250 mg Injection. Laboratories.
Base/Vial; EQ
500 mg Base/
Vial; EQ 1 gram
(g) Base/Vial;
EQ 2 g Base/
Vial; EQ 4 g
Base/Vial.
NDA 050309............ POLYCILLIN-N.... Ampicillin EQ 125 mg Base/ Injectable; Bristol
Sodium. Vial; EQ 250 mg Injection. Laboratories
Base/Vial; EQ Inc.
500 mg Base/
Vial; EQ 1 g
Base/Vial; EQ 2
g Base/Vial.
NDA 050674............ VANTIN.......... Cefpodoxime EQ 100 mg Base; Tablet; Oral.... Pharmacia and
Proxetil. EQ 200 mg Base. Upjohn Co.
ANDA 064170........... CEFAZOLIN SODIUM Cefazolin Sodium EQ 10 g Base/ Injectable; Fresenius Kabi
Vial; EQ 20 g Injection. USA, LLC.
Base/Vial.
ANDA 075406........... OGESTREL 0.5/50- Ethinyl 0.05 mg; 0.5 mg. Tablet; Oral-21. Watson
21. Estradiol; Laboratories,
Norgestrel. Inc.
ANDA 085106........... PERCOCET........ Acetaminophen; 325 mg; 5 mg.... Tablet; Oral.... Vintage
Oxycodone Pharmaceuticals
Hydrochloride. LLC.
ANDA 089351........... ROXICET......... Acetaminophen; 325 mg/5 mL; 5 Solution; Oral.. West-Ward
Oxycodone mg/5 mL. Pharmaceuticals
Hydrochloride. International
Ltd.
ANDA 089456........... PERPHENAZINE.... Perphenazine.... 8 mg............ Tablet; Oral.... ANI
Pharmaceuticals
, Inc.
ANDA 089457........... PERPHENAZINE.... Perphenazine.... 16 mg........... Tablet; Oral.... Teva
Pharmaceuticals
USA.
ANDA 089707........... PERPHENAZINE.... Perphenazine.... 2 mg............ Tablet; Oral.... Ditto.
ANDA 089708........... PERPHENAZINE.... Perphenazine.... 4 mg............ Tablet; Oral.... Do.
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FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document 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 in this
document 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.
This is not a significant regulatory action subject to Executive
Order 12866, and does not impose any additional burden on regulated
entities.
Dated: April 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08582 Filed 4-27-17; 8:45 am]
BILLING CODE 4164-01-P