[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Products Were Not Withdrawn From Sale for Reasons of Safety or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drug products listed in this document were not withdrawn from sale for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, [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
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).)
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Application No. Drug Applicant
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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.
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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.
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