Determination That Adderall (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate) Tablet and 13 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 67365-67367 [2013-26856]

Download as PDF Federal Register / Vol. 78, No. 218 / Tuesday, November 12, 2013 / Notices Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Karen Abraham-Burrell at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: November 5, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2013–26868 Filed 11–8–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. emcdonald on DSK67QTVN1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on December 11, 2013, from 8 a.m. to 6 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel’s telephone number is 301–977–8900. Contact Person: Jamie Waterhouse, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver VerDate Mar<15>2010 17:41 Nov 08, 2013 Jkt 232001 Spring, MD 20993, 301–796–3063, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at http:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On December 11, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application regarding the Boston Scientific WATCHMAN Left Atrial Appendage (LAA) Closure Technology. The WATCHMAN LAA Closure Technology is a percutaneously delivered permanent cardiac implant placed in the left atrial appendage. This device is intended to prevent thrombus embolization from the left atrial appendage, thereby preventing the occurrence of ischemic stroke and systemic embolism, and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who are eligible for warfarin therapy. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 27, 2013. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 67365 participants, and an indication of the approximate time requested to make their presentation on or before November 19, 2013. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 20, 2013. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Ann Marie Williams, Conference Management Staff, at AnnMarie.Williams@ fda.hhs.gov or 301–796–5966 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: November 5, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2013–26891 Filed 11–8–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1361] Determination That Adderall (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate) Tablet and 13 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: E:\FR\FM\12NON1.SGM Notice. 12NON1 67366 Federal Register / Vol. 78, No. 218 / Tuesday, November 12, 2013 / Notices 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. SUMMARY: FOR FURTHER INFORMATION CONTACT: Amy Hopkins, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993–0002, 301– 796–5418. 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 sponsors 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. Sponsors of ANDAs 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 § 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 NDA 011522 ........................ ADDERALL (amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate) Tablet; Oral, 5 milligrams (mg), 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, 30 mg. KENALOG (triamcinolone acetonide) Cream; Topical, 0.025%, 0.1%. MUCOMYST (acetylcysteine) Solution; Inhalation, Oral, 10%, 20%. NITROGLYCERIN (nitroglycerin) Injectable; Injection, 5mg/milliliter (mL). WESTCORT (hydrocortisone valerate) Ointment; Topical, 0.2%. TAMBOCOR (flecainide acetate) Tablet; Oral, 50 mg, 100 mg, 150 mg. DYNACIRC CR (isradipine) Tablet; Extended Release, Oral, 5 mg, 10 mg. RETROVIR (zidovudine) Tablet; Oral, 300 mg .............. Teva Womens Health Inc., 41 Moores Rd., P.O. Box 4011, Frazer, PA 19355. NDA 011601 ........................ NDA 013601 ........................ NDA 018531 ........................ NDA 018726 ........................ NDA 018830 ........................ NDA 020336 ........................ NDA 020518 ........................ NDA 021745 ........................ ANDA 081295 ...................... RYZOLT (tramadol HCl) Tablet; Extended Release, Oral, 100 mg, 200 mg, 300 mg. ALTACE (ramipril) Tablet; Oral, 1.25 mg, 2.5 mg, 5 mg, 10 mg. SOLODYN (minocycline HCl) Tablet; Extended Release; Equivalent to (EQ) 45 mg Base, EQ 90 mg Base, EQ 135 mg Base. ESTRACE (estradiol) Tablet; Oral, 0.5 mg ..................... ANDA 084499 ...................... ANDA 084500 ...................... ESTRACE (estradiol) Tablet; Oral, 1 mg ........................ ESTRACE (estradiol) Tablet; Oral, 2 mg ........................ NDA 022021 ........................ emcdonald on DSK67QTVN1PROD with NOTICES NDA 050808 ........................ FDA has reviewed its records and, under § 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 VerDate Mar<15>2010 17:41 Nov 08, 2013 Jkt 232001 Apothecon Pharmaceuticals, General Offices, P.O. Box 4500, Princeton, NJ 08543–4500. Do. Hospira Inc., 275 North Field Dr., Bldg. H2, Lake Forest, IL 60045–5046. Ranbaxy Inc., 600 College Rd., East Princeton, NJ 08540. Medicis Pharmaceutical Corp., 7720 North Dobson Rd., Scottsdale, AZ 85256. GlaxoSmithKline LLC., 2711 Centerville Rd., Ste. 400, Wilmington, DE 19808. ViiV Healthcare, 5 Moore Dr., Research Triangle Park, NC 27709. Purdue Pharma Products LP, 1 Stamford Forum, Stamford, CT 06901. Pfizer Inc., 501 5th St., Bristol, TN 37620. Medicis Pharmaceutical Corp., 7720 North Dobson Rd., Scottsdale, AZ 85256. Bristol Myers Squibb, P.O. Box 4000, Princeton, NJ 08543. Do. Do. ‘‘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. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 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. E:\FR\FM\12NON1.SGM 12NON1 67367 Federal Register / Vol. 78, No. 218 / Tuesday, November 12, 2013 / Notices Dated: November 5, 2013. Leslie Kux, Assistant Commissioner for Policy. or call the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. [FR Doc. 2013–26856 Filed 11–8–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Information Collection Request Title: Ryan White HIV/AIDS Program Core Medical Services Waiver Application Requirements Health Resources and Services Administration Agency Information Collection Activities; Proposed Collection; Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received within 60 days of this notice. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 10–29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov SUMMARY: OMB No. 0915–0307—Revision Abstract: Title XXVI of the Public Health Service (PHS) Act, as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Ryan White HIV/ AIDS Program), Part A section 2604(c), Part B section 2612(b), and Part C section 2651(c), requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs for individuals with HIV/AIDS, identified and eligible under the legislation. In order for grantees under Parts A, B, and C to be exempted from the 75 percent core medical services requirement, they must request and receive a waiver from HRSA, as required in the Act. On October 25, 2013, HRSA published revised standards for core medical services waiver requests in the Federal Register (78 FR 63990). These revised standards will allow grantees more flexibility to adjust resource allocation based on the current situation in their local environment. These standards ensure that grantees receiving waivers demonstrate the availability of core medical services, including antiretroviral drugs, for persons with HIV/AIDS served under Title XXVI of the PHS Act. The core medical services waiver uniform standard and waiver request process will apply to Ryan White HIV/AIDS Program Grant Awards under Parts A, B, and C of Title XXVI of the PHS Act. Core medical services Number of respondents Form name Number of responses per respondent waivers will be effective for a 1-year period that is consistent with the grant award period. Grantees may submit a waiver request before the annual grant application, with the application, or up to 4 months after the grant award has been made. Need and Proposed Use of the Information: HRSA uses the documentation submitted in core medical services waiver requests to determine if the applicant/grantee meets the statutory requirements for waiver eligibility including: (1) No waiting lists for AIDS Drug Assistance Program (ADAP) services; and (2) evidence of core medical services availability within the grantee’s jurisdiction, state, or service area to all individuals with HIV/ AIDS identified and eligible under Title XXVI of the PHS Act. See sections 2604(c)(2), 2612(b)(2), and 2651(c)(2) of the PHS Act. Likely Respondents: Ryan White HIV/ AIDS Program Part A, B, and C grantees. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. Total Estimated Annualized burden hours: Total responses Average burden per response (in hours) Total burden hours 20 1 20 5.5 110 Total .............................................................................. emcdonald on DSK67QTVN1PROD with NOTICES Waiver Request ................................................................... 20 1 20 5.5 110 HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques VerDate Mar<15>2010 17:41 Nov 08, 2013 Jkt 232001 or other forms of information technology to minimize the information collection burden. PO 00000 Dated: November 4, 2013. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2013–26974 Filed 11–8–13; 8:45 am] BILLING CODE 4165–15–P Frm 00037 Fmt 4703 Sfmt 9990 E:\FR\FM\12NON1.SGM 12NON1

Agencies

[Federal Register Volume 78, Number 218 (Tuesday, November 12, 2013)]
[Notices]
[Pages 67365-67367]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26856]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1361]


Determination That Adderall (Amphetamine Aspartate; Amphetamine 
Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate) 
Tablet and 13 Other Drug Products Were Not Withdrawn From Sale for 
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

[[Page 67366]]

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. 6207, Silver Spring, MD 20993-0002, 301-
796-5418.

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 
sponsors 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. Sponsors of ANDAs 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
------------------------------------------------------------------------
NDA 011522..................  ADDERALL              Teva Womens Health
                               (amphetamine          Inc., 41 Moores
                               aspartate;            Rd., P.O. Box 4011,
                               amphetamine           Frazer, PA 19355.
                               sulfate;
                               dextroamphetamine
                               saccharate;
                               dextroamphetamine
                               sulfate) Tablet;
                               Oral, 5 milligrams
                               (mg), 7.5 mg, 10
                               mg, 12.5 mg, 15 mg,
                               20 mg, 30 mg.
NDA 011601..................  KENALOG               Apothecon
                               (triamcinolone        Pharmaceuticals,
                               acetonide) Cream;     General Offices,
                               Topical, 0.025%,      P.O. Box 4500,
                               0.1%.                 Princeton, NJ 08543-
                                                     4500.
NDA 013601..................  MUCOMYST              Do.
                               (acetylcysteine)
                               Solution;
                               Inhalation, Oral,
                               10%, 20%.
NDA 018531..................  NITROGLYCERIN         Hospira Inc., 275
                               (nitroglycerin)       North Field Dr.,
                               Injectable;           Bldg. H2, Lake
                               Injection, 5mg/       Forest, IL 60045-
                               milliliter (mL).      5046.
NDA 018726..................  WESTCORT              Ranbaxy Inc., 600
                               (hydrocortisone       College Rd., East
                               valerate) Ointment;   Princeton, NJ
                               Topical, 0.2%.        08540.
NDA 018830..................  TAMBOCOR (flecainide  Medicis
                               acetate) Tablet;      Pharmaceutical
                               Oral, 50 mg, 100      Corp., 7720 North
                               mg, 150 mg.           Dobson Rd.,
                                                     Scottsdale, AZ
                                                     85256.
NDA 020336..................  DYNACIRC CR           GlaxoSmithKline
                               (isradipine)          LLC., 2711
                               Tablet; Extended      Centerville Rd.,
                               Release, Oral, 5      Ste. 400,
                               mg, 10 mg.            Wilmington, DE
                                                     19808.
NDA 020518..................  RETROVIR              ViiV Healthcare, 5
                               (zidovudine)          Moore Dr., Research
                               Tablet; Oral, 300     Triangle Park, NC
                               mg.                   27709.
NDA 021745..................  RYZOLT (tramadol      Purdue Pharma
                               HCl) Tablet;          Products LP, 1
                               Extended Release,     Stamford Forum,
                               Oral, 100 mg, 200     Stamford, CT 06901.
                               mg, 300 mg.
NDA 022021..................  ALTACE (ramipril)     Pfizer Inc., 501 5th
                               Tablet; Oral, 1.25    St., Bristol, TN
                               mg, 2.5 mg, 5 mg,     37620.
                               10 mg.
NDA 050808..................  SOLODYN (minocycline  Medicis
                               HCl) Tablet;          Pharmaceutical
                               Extended Release;     Corp., 7720 North
                               Equivalent to (EQ)    Dobson Rd.,
                               45 mg Base, EQ 90     Scottsdale, AZ
                               mg Base, EQ 135 mg    85256.
                               Base.
ANDA 081295.................  ESTRACE (estradiol)   Bristol Myers
                               Tablet; Oral, 0.5     Squibb, P.O. Box
                               mg.                   4000, Princeton, NJ
                                                     08543.
ANDA 084499.................  ESTRACE (estradiol)   Do.
                               Tablet; Oral, 1 mg.
ANDA 084500.................  ESTRACE (estradiol)   Do.
                               Tablet; Oral, 2 mg.
------------------------------------------------------------------------

    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.


[[Page 67367]]


    Dated: November 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26856 Filed 11-8-13; 8:45 am]
BILLING CODE 4160-01-P