[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Pages 47648-47649]
From the Federal Register Online via the Government Publishing 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Withdrawn From Sale for Reasons of Safety or Effectiveness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drug products listed in this document were not withdrawn from sale for 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, [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.
    FDA has become aware that the drug products listed in the table in 
this document are no longer being marketed.

------------------------------------------------------------------------
        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