[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and Other Drug Products Were Not Withdrawn From Sale for Reasons of 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withdrawn from sale for reasons of safety or effectiveness.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.

----------------------------------------------------------------------------------------------------------------
                                               Active                           Dosage form/
    Application No.         Drug name       ingredient(s)      Strength(s)          route           Applicant
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

    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