[Federal Register Volume 80, Number 6 (Friday, January 9, 2015)]
[Notices]
[Pages 1423-1424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00116]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2258]


Determination That TAGAMET (Cimetidine) 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Products Were Not Withdrawn From Sale for Reasons of Safety or 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) 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drug products listed in this document were not withdrawn from sale for 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: Amy Hopkins, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6223, Silver Spring, MD 20993-0002, 301-
796-5418, <a href="/cdn-cgi/l/email-protection#08496571264067786361667b486e6c692660607b266f677e"><span class="__cf_email__" data-cfemail="c988a4b0e781a6b9a2a0a7ba89afada8e7a1a1bae7aea6bf">[email protected]</span></a>.

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 
effectiveness reasons, the Agency will initiate proceedings that could 
result in the withdrawal of approval of the ANDAs that refer to the 
listed drug.

[[Page 1424]]

    FDA has become aware that the drug products listed in the table in 
this document are no longer being marketed. (As requested by the 
applicants, FDA withdrew approval of NDA 017920 for TAGAMET 
(cimetidine) Tablets in the Federal Register of June 8, 2011 (76 FR 
33310), and NDA 018709 for CAPOZIDE (captopril and hydrochlorothiazide) 
Tablets in the Federal Register of March 19, 2012 (77 FR 16039).)

 
------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 017920.............  TAGAMET (cimetidine)     GlaxoSmithKline, 5
                          Tablet; Oral, 200        Moore Dr., P.O. Box
                          milligram (mg); 300      13398, Research
                          mg; 400 mg; 800 mg.      Triangle Park, NC
                                                   27709.
NDA 018155.............  OPTICROM (cromolyn       Allergan Inc., 2525
                          sodium) Solution/        Dupont Dr., Irvine,
                          Drops; Ophthalmic, 4%.   CA 92623.
NDA 018709.............  CAPOZIDE (captopril and  Apothecon Inc., P.O.
                          hydrochlorothiazide)     Box 4500, Princeton,
                          Tablet; Oral, 25 mg/15   NJ 08543.
                          mg; 25 mg/25 mg; 50 mg/
                          15 mg; 50 mg/25 mg.
NDA 018976.............  LEVATOL (penbutolol      Auxilium
                          sulfate) Tablet; Oral,   Pharmaceuticals LLC,
                          10 mg; 20 mg.            640 Lee Rd.,
                                                   Chesterbrook, PA
                                                   19087.
NDA 019958.............  CUTIVATE (fluticasone    Fougera
                          propionate) Cream;       Pharmaceuticals Inc.,
                          Topical, 0.05%.          1 Health Plaza, Bldg.
                                                   434, East Hanover, NJ
                                                   07936.
NDA 020713.............  MIRCETTE (desogestrel    Teva Pharmaceutical
                          and ethinyl estradiol,   Products Inc., 41
                          and ethinyl estradiol)   Moores Rd, P.O. Box
                          Tablet; Oral-28, 0.15    4011, Frazer, PA
                          mg/0.02 mg; 0.01 mg.     19355.
NDA 021410.............  AVANDAMET (metformin     SmithKline Beecham
                          hydrochloride (HCl)      Cork Ltd., Ireland,
                          and rosiglitazone        2301 Renaissance
                          maleate) Tablet; Oral,   Blvd., MC RN 0420,
                          500 mg/Equivalent to 1   King of Prussia, PA
                          mg Base.                 19406.
NDA 021571.............  IQUIX (levofloxacin)     Santen Inc., 555
                          Solution/Drops;          Gateway Dr., Napa, CA
                          Ophthalmic, 1.5%.        94558.
NDA 021726.............  NIRAVAM (alprazolam)     UCB Inc., 1950 Lake
                          Orally Disintegrating    Park Dr., Smyrna, GA
                          Tablets; Oral, 0.25      30080.
                          mg; 0.5 mg; 1 mg; 2 mg.
NDA 021768.............  FLUDEOXYGLUCLOSE F-18    Weill Medical College
                          Injectable;              Cornell University,
                          Intravenous 10-100       516 East 72nd St.,
                          millicuries/milliliter.  New York, NY 10065.
ANDA 076699............  PARCOPA (carbidopa and   UCB Inc., 1950 Lake
                          levodopa) Orally         Park Dr., Smyrna, GA
                          Disintegrating           30080.
                          Tablets; Oral, 10 mg/
                          100 mg; 25 mg/100 mg;
                          25 mg/250 mg.
ANDA 080248............  ALBALON (naphazoline     Allergan Inc., 2525
                          HCl) Solution/Drops;     Dupont Dr., Irvine,
                          Ophthalmic, 0.1%.        CA 92623.
------------------------------------------------------------------------

    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.

    Dated: January 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00116 Filed 1-8-15; 8:45 am]
BILLING CODE 4164-01-P


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