80 FR 75867 - Determination That OPHTHAINE (proparacaine hydrochloride) Solution and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 233 (December 4, 2015)

Page Range		75867-75868
FR Document		2015-30628

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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.

Federal Register, Volume 80 Issue 233 (Friday, December 4, 2015)

[Federal Register Volume 80, Number 233 (Friday, December 4, 2015)]
[Notices]
[Pages 75867-75868]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30628]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-4399]


Determination That OPHTHAINE (proparacaine hydrochloride) 
Solution and Other Drug Products Were Not Withdrawn From Sale for 
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that the drug products listed in this document were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination means

[[Page 75868]]

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: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, 
[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
------------------------------------------------------------------------
NDA 008883.............  OPHTHAINE (proparacaine  Apothecon, Inc.
                          hydrochloride)
                          Solution/Drops;
                          Ophthalmic, 0.5%.
NDA 009053.............  PURINETHOL               Teva Pharmaceuticals
                          (mercaptopurine)         USA.
                          Tablet; Oral, 50
                          milligrams (mg).
NDA 012427.............  DIDREX (benzphetamine    Pharmacia & Upjohn Co.
                          hydrochloride) Tablet;
                          Oral, 50 mg.
NDA 012583.............  OPHTHETIC (proparacaine  Allergan
                          hydrochloride)           Pharmaceutical.
                          Solution/Drops;
                          Ophthalmic, 0.5%.
NDA 017716.............  OVCON-35 (ethinyl        Warner Chilcott LLC.
                          estradiol;
                          norethindrone) Tablet;
                          Oral-28, 0.035 mg; 0.4
                          mg.
NDA 018782.............  NORDETTE-28 (ethinyl     Teva Branded
                          estradiol;               Pharmaceutical
                          levonorgestrel)          Products R and D,
                          Tablet; Oral-28, 0.03    Inc.
                          mg; 0.15 mg.
NDA 021199.............  QUIXIN (levofloxacin)    Santen, Inc.
                          Solution/Drops;
                          Ophthalmic, 0.5%.
NDA 021595.............  SANCTURA (trospium       Allergan, Inc.
                          chloride) Tablet;
                          Oral, 20 mg.
NDA 021664.............  BROMDAY (bromfenac       Bausch & Lomb, Inc.
                          sodium) Solution/
                          Drops; Ophthalmic, EQ
                          0.09% acid.
NDA 022103.............  SANCTURA XR (trospium    Allergan, Inc.
                          chloride) Extended-
                          Release Capsule; Oral,
                          60 mg.
ANDA 060571............  MYCOSTATIN (nystatin)    Delcor Asset Corp.
                          Ointment; Topical,
                          100,000 units/gram (g).
ANDA 060575............  MYCOSTATIN (nystatin)    Do.
                          Cream; Topical,
                          100,000 units/g.
ANDA 060578............  MYCOSTATIN (nystatin)    Do.
                          Powder; Topical
                          100,000 units/g.
ANDA 063116............  TOBRAMYCIN SULFATE       Hospira, Inc.
                          (PHARMACY BULK)
                          (tobramycin sulfate)
                          Injectable; Injection,
                          EQ 40 mg base/
                          milliliter.
------------------------------------------------------------------------

    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: November 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-30628 Filed 12-3-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Notices 75867

conditions that an ASC must meet in We have 210 days from the receipt of a unannounced, to assure that surveys are
order to participate in the Medicare complete application to publish notice unannounced.
program, the scope of covered services, of approval or denial of the application. ++ IMQ’s agreement to provide CMS
and the conditions for Medicare The purpose of this proposed notice with a copy of the most current
payment for ASCs. is to inform the public of the Institute accreditation survey together with any
Generally, to enter into an agreement, for Medical Quality (IMQ’s) request for other information related to the survey
an ASC must first be certified by a State initial CMS-approval of its ASC as CMS may require (including
survey agency as complying with the accreditation program. This notice also corrective action plans).
conditions or requirements set forth in solicits public comment on whether
part 416 of our Medicare regulations. IV. Collection of Information
IMQ’s requirements meet or exceed the
Thereafter, the ASC is subject to regular Requirements
Medicare conditions for coverage (CfCs)
surveys by a State survey agency to for ASCs. This document does not impose
determine whether it continues to meet information collection requirements,
these requirements. III. Evaluation of a NAO’s that is, reporting, recordkeeping or
Section 1865(a)(1) of the Act provides Accreditation Program third-party disclosure requirements.
that, if a provider entity demonstrates IMQ submitted all the necessary Consequently, there is no need for
through accreditation by a Centers for materials to enable us to make a review by the Office of Management and
Medicare & Medicaid Services (CMS) determination concerning its request for Budget under the authority of the
approved national accrediting initial CMS-approval of its ASC Paperwork Reduction Act of 1995 (44
organization (NAO) that all applicable accreditation program. This application U.S.C. 3501 et seq.).
Medicare conditions are met or was determined to be complete on
exceeded, we may deem those provider V. Response to Public Comments
October 8, 2015. Under Section
entities as having met the requirements. 1865(a)(2) of the Act and our regulations Because of the large number of public
Accreditation by an NAO is voluntary at § 488.5, our review and evaluation of comments we normally receive on
and is not required for Medicare IMQ will be conducted in accordance Federal Register documents, we are not
participation. with, but not necessarily limited to, the able to acknowledge or respond to them
If an NAO is recognized by the following factors: individually. We will consider all
Secretary of the Department of Health • The equivalency of IMQ’s standards comments we receive by the date and
and Human Services as having for ASCs as compared with Medicare’s time specified in the DATES section of
standards for accreditation that meet or CfCsf or ASCs. this preamble, and, when we proceed
exceed Medicare requirements, any • IMQ’s survey process to determine with a subsequent document, we will
provider entity accredited by the the following: respond to the comments in the
national accrediting body’s approved ++ The composition of the survey preamble to that document.
program may be deemed to meet the team, surveyor qualifications, and the Upon completion of our evaluation,
Medicare conditions. A NAO applying ability of the organization to provide including evaluation of comments
for approval of its accreditation program continuing surveyor training. received as a result of this notice, we
under part 488, subpart A, must provide ++ The comparability of IMQ’s will publish a final notice in the Federal
CMS with reasonable assurance that the processes to those of State agencies, Register announcing the result of our
NAO requires the accredited provider including survey frequency, and the evaluation.
entities to meet requirements that are at ability to investigate and respond Dated: November 18, 2015.
least as stringent as the Medicare appropriately to complaints against Andrew M. Slavitt,
conditions. Our regulations concerning accredited facilities. Acting Administrator, Centers for Medicare
the approval of NAOs are set forth at ++ IMQ’s processes and procedures & Medicaid Services.
§ 488.5. for monitoring an ASC found out of
[FR Doc. 2015–30316 Filed 12–3–15; 8:45 am]
compliance with IMQ’s program
II. Approval of Deeming Organizations BILLING CODE 4120–01–P
requirements. These monitoring
Section 1865(a)(2) of the Act and our procedures are used only when IMQ
regulations at § 488.5 require that our identifies noncompliance. If
findings concerning review and DEPARTMENT OF HEALTH AND
noncompliance is identified through HUMAN SERVICES
approval of a NAO’s requirements validation reviews or complaint
consider, among other factors, the surveys, the State survey agency Food and Drug Administration
applying NAO’s requirements for monitors corrections as specified at
accreditation; survey procedures; § 488.9(c)(1). [Docket No. FDA–2015–N–4399]
resources for conducting required ++ IMQ’s capacity to report
surveys; capacity to furnish information Determination That OPHTHAINE
deficiencies to the surveyed facilities
for use in enforcement activities; (proparacaine hydrochloride) Solution
and respond to the facility’s plan of
monitoring procedures for provider and Other Drug Products Were Not
correction in a timely manner.
entities found not in compliance with ++ IMQ’s capacity to provide CMS Withdrawn From Sale for Reasons of
the conditions or requirements; and with electronic data and reports Safety or Effectiveness
ability to provide CMS with the necessary for effective validation and AGENCY: Food and Drug Administration,
necessary data for validation.
asabaliauskas on DSK5VPTVN1PROD with NOTICES

assessment of the organization’s survey HHS.
Section 1865(a)(3)(A) of the Act process. ACTION: Notice.
further requires that we publish, within ++ The adequacy of IMQ’s staff and
60 days of receipt of an organization’s other resources, and its financial SUMMARY: The Food and Drug
complete application, a notice viability. Administration (FDA or Agency) has
identifying the national accrediting ++ IMQ’s capacity to adequately fund determined that the drug products listed
body making the request, describing the required surveys. in this document were not withdrawn
nature of the request, and providing at ++ IMQ’s policies with respect to from sale for reasons of safety or
least a 30-day public comment period. whether surveys are announced or effectiveness. This determination means

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75868 Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Notices

that FDA will not begin procedures to exceptions, show that the drug for was withdrawn from sale for reasons of
withdraw approval of abbreviated new which they are seeking approval safety or effectiveness (21 CFR 314.162).
drug applications (ANDAs) that refer to contains the same active ingredient in Under § 314.161(a) (21 CFR
these drug products, and it will allow the same strength and dosage form as 314.161(a)), the Agency must determine
FDA to continue to approve ANDAs that the ‘‘listed drug,’’ which is a version of whether a listed drug was withdrawn
refer to the products as long as they the drug that was previously approved. from sale for reasons of safety or
meet relevant legal and regulatory ANDA applicants do not have to repeat effectiveness: (1) Before an ANDA that
requirements. the extensive clinical testing otherwise refers to that listed drug may be
necessary to gain approval of a new
FOR FURTHER INFORMATION CONTACT: approved, (2) whenever a listed drug is
drug application (NDA).
Stacy Kane, Center for Drug Evaluation The 1984 amendments include what voluntarily withdrawn from sale and
and Research, Food and Drug is now section 505(j)(7) of the Federal ANDAs that refer to the listed drug have
Administration, 10903 New Hampshire Food, Drug, and Cosmetic Act (21 U.S.C. been approved, and (3) when a person
Ave., Bldg. 51, Rm. 6236, Silver Spring, 355(j)(7)), which requires FDA to petitions for such a determination under
MD 20993–0002, 301–796–8363, publish a list of all approved drugs. 21 CFR 10.25(a) and 10.30. Section
Stacy.Kane@fda.hhs.gov. FDA publishes this list as part of the 314.161(d) provides that if FDA
SUPPLEMENTARY INFORMATION: In 1984, ‘‘Approved Drug Products With determines that a listed drug was
Congress enacted the Drug Price Therapeutic Equivalence Evaluations,’’ withdrawn from sale for safety or
Competition and Patent Term which is generally known as the effectiveness reasons, the Agency will
Restoration Act of 1984 (Pub. L. 98–417) ‘‘Orange Book.’’ Under FDA regulations, initiate proceedings that could result in
(the 1984 amendments), which a drug is removed from the list if the the withdrawal of approval of the
authorized the approval of duplicate Agency withdraws or suspends ANDAs that refer to the listed drug.
versions of drug products approved approval of the drug’s NDA or ANDA FDA has become aware that the drug
under an ANDA procedure. ANDA for reasons of safety or effectiveness, or products listed in the table in this
applicants must, with certain if FDA determines that the listed drug document are no longer being marketed.

Application No. Drug Applicant

NDA 008883 ...... OPHTHAINE (proparacaine hydrochloride) Solution/Drops; Apothecon, Inc.
Ophthalmic, 0.5%.
NDA 009053 ...... PURINETHOL (mercaptopurine) Tablet; Oral, 50 milligrams Teva Pharmaceuticals USA.
(mg).
NDA 012427 ...... DIDREX (benzphetamine hydrochloride) Tablet; Oral, 50 mg Pharmacia & Upjohn Co.
NDA 012583 ...... OPHTHETIC (proparacaine hydrochloride) Solution/Drops; Allergan Pharmaceutical.
Ophthalmic, 0.5%.
NDA 017716 ...... OVCON–35 (ethinyl estradiol; norethindrone) Tablet; Oral-28, Warner Chilcott LLC.
0.035 mg; 0.4 mg.
NDA 018782 ...... NORDETTE–28 (ethinyl estradiol; levonorgestrel) Tablet; Teva Branded Pharmaceutical Products R and D, Inc.
Oral-28, 0.03 mg; 0.15 mg.
NDA 021199 ...... QUIXIN (levofloxacin) Solution/Drops; Ophthalmic, 0.5% ....... Santen, Inc.
NDA 021595 ...... SANCTURA (trospium chloride) Tablet; Oral, 20 mg .............. Allergan, Inc.
NDA 021664 ...... BROMDAY (bromfenac sodium) Solution/Drops; Ophthalmic, Bausch & Lomb, Inc.
EQ 0.09% acid.
NDA 022103 ...... SANCTURA XR (trospium chloride) Extended-Release Cap- Allergan, Inc.
sule; Oral, 60 mg.
ANDA 060571 .... MYCOSTATIN (nystatin) Ointment; Topical, 100,000 units/ Delcor Asset Corp.
gram (g).
ANDA 060575 .... MYCOSTATIN (nystatin) Cream; Topical, 100,000 units/g ..... Do.
ANDA 060578 .... MYCOSTATIN (nystatin) Powder; Topical 100,000 units/g ..... Do.
ANDA 063116 .... TOBRAMYCIN SULFATE (PHARMACY BULK) (tobramycin Hospira, Inc.
sulfate) Injectable; Injection, EQ 40 mg base/milliliter.

FDA has reviewed its records and, document are unaffected by the DEPARTMENT OF HEALTH AND
under § 314.161, has determined that discontinued marketing of the products HUMAN SERVICES
the drug products listed in this subject to those NDAs and ANDAs.
document were not withdrawn from Additional ANDAs that refer to these National Institutes of Health
sale for reasons of safety or products may also be approved by the
effectiveness. Accordingly, the Agency Agency if they comply with relevant National Institute on Drug Abuse;
legal and regulatory requirements. If Notice of Closed Meeting
will continue to list the drug products
listed in this document in the FDA determines that labeling for these
Pursuant to section 10(d) of the
‘‘Discontinued Drug Product List’’ drug products should be revised to meet
Federal Advisory Committee Act, as
asabaliauskas on DSK5VPTVN1PROD with NOTICES

section of the Orange Book. The current standards, the Agency will
amended (5 U.S.C. App), notice is
‘‘Discontinued Drug Product List’’ advise ANDA applicants to submit such
hereby given of the following meeting.
identifies, among other items, drug labeling.
The meeting will be closed to the
products that have been discontinued Dated: November 30, 2015.
public in accordance with the
from marketing for reasons other than Leslie Kux, provisions set forth in sections
safety or effectiveness. Associate Commissioner for Policy. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Approved ANDAs that refer to the [FR Doc. 2015–30628 Filed 12–3–15; 8:45 am] as amended. The grant applications and
NDAs and ANDAs listed in this BILLING CODE 4164–01–P the discussions could disclose

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Document Created: 2015-12-14 13:52:44
Document Modified: 2015-12-14 13:52:44

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, [email protected]
FR Citation		80 FR 75867

80 FR 75867 - Determination That OPHTHAINE (proparacaine hydrochloride) Solution and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 233 (December 4, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration