[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Pages 47648-47649]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19272]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1139]
Determination That DRIXORAL (Dexbrompheniramine Maleate;
Pseudoephedrine Sulfate) Tablet 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Withdrawn From Sale for Reasons of Safety or Effectiveness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drug products listed in this document were not withdrawn from sale for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, Amy.Hopkins@fda.hhs.gov.
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.
FDA has become aware that the drug products listed in the table in
this document are no longer being marketed.
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Application No. Drug Applicant
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NDA 013483.................... DRIXORAL MSD Consumer Care
(dexbrompheniramin Inc., 556 Morris
e maleate and Ave., Summit, NJ
pseudoephedrine 07901.
sulfate) Tablet,
Extended Release;
Oral, 6 milligrams
(mg)/120 mg.
NDA 014685.................... AVENTYL Ranbaxy
(nortriptyline Pharmaceuticals
hydrochloride Inc., 600 College
(HCl)) Solution; Rd. East,
Oral, Equivalent Princeton, NJ
to (EQ) 10 mg Base/ 08540.
5mL.
[[Page 47649]]
NDA 016418.................... INDERAL Wyeth
(propranolol HCl) Pharmaceuticals
Tablet; Oral, 80 Inc., C/O Pfizer
mg. Inc., 235 East
42nd St., New
York, NY 10017.
NDA 016909.................... LIDEX County Line
(fluocinonide) Pharmaceuticals,
Ointment; Topical LLC, 13890
0.05%. Bishop's Dr.,
Suite 410,
Brookfield, WI
53005.
NDA 017373.................... LIDEX .....Do.
(fluocinonide)
Gel; Topical 0.05%.
NDA 020073.................... ROMAZICON Hoffmann-La Roche
(flumazenil) Inc., C/O
Injectable; Genentech Inc., 1
Injection, 1 mg/10 DNA Way, South San
milliliters (mL) Francisco, CA
(0.1 mg/mL); 0.5 94080-4990.
mg/5 mL (0.1 mg/
mL).
NDA 020229.................... LEUSTATIN Janssen
(cladribine) Pharmaceuticals
Injectable; Inc., C/O Johnson
Injection, 1 mg/mL. and Johnson
Pharmaceutical
Research and
Development LLC,
920 Rt. 202 South,
P.O. Box 300,
Raritan, NJ 08869.
NDA 020347.................... HYTRIN (terazosin Abbott Laboratories
HCl) Capsule; Pharmaceutical
Oral, EQ 1 mg Products Division,
Base; EQ 2 mg Dept. 491 AP6B 1,
Base; EQ 5 mg Abbott Park, IL
Base; EQ 10 mg 60064.
Base.
NDA 020560.................... FOSAMAX Merck and Co. Inc.,
(alendronate 126 East Lincoln
sodium) Tablet; Ave., RY 33 212,
Oral, EQ 5 mg P.O. Box 2000,
Base; EQ 10 mg Rahway, NJ 07065-
Base; EQ 35 mg 0900.
Base; EQ 40 mg
Base.
NDA 020813.................... KLONOPIN Hoffmann-La Roche
(clonazepam) Inc., 340
Tablet, Orally Kingsland St.,
Disintegrating Nutley, NJ 07110.
Tablet (ODT);
Oral, 0.125 mg,
0.25 mg, 0.5 mg, 1
mg, 2 mg.
NDA 021046.................... CELEXA (citalopram Forest Laboratories
hydrobromide) Inc., Harborside
Solution; Oral, EQ Financial Center,
10 mg Base/5 mL. Plaza V, Suite
1900, Jersey City,
NJ 07311.
NDA 022246.................... METOZOLV ODT Salix
(metoclopramide Pharmaceuticals
HCl) Tablet, ODT; Inc., 8510
Oral, EQ 10 mg Colonnade Center
Base. Dr., Raleigh, NC
27615.
NDA 050533.................... VIBRA-TABS Pfizer Laboratories
(doxycycline Inc., 235 East
hyclate) Tablet; 42nd St., New
Oral, EQ 100 mg York, NY 10017.
Base.
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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 listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. 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: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19272 Filed 8-13-14; 8:45 am]
BILLING CODE 4164-01-P