81 FR 36312 - Determination That APRESOLINE (Hydralazine Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 81, Issue 108 (June 6, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 108 (June 6, 2016)
| Page Range | 36312-36313 | |
| FR Document | 2016-13181 |
[Federal Register Volume 81, Number 108 (Monday, June 6, 2016)] [Notices] [Pages 36312-36313] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13181] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1284] Determination That APRESOLINE (Hydralazine Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 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. [[Page 36313]] 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 following table are no longer being marketed. ---------------------------------------------------------------------------------------------------------------- Active Dosage form/ Application No. Drug name ingredient(s) Strength(s) route Applicant ---------------------------------------------------------------------------------------------------------------- NDA 008303........... APRESOLINE........... Hydralazine 20 milligrams Injectable; Novartis Hydrochloride;. (mg)/ Injection Pharmaceutical milliliter 10 Tablet; Oral. s Corp. mg; 25 mg; 50 mg; 100 mg. NDA 017853........... PROVENTIL............ Albuterol Equivalent to Tablet; Oral... Schering-Plough Sulfate. (EQ) 2 mg Corp. base; EQ 4 mg base. NDA 019439........... K-Dur................ Potassium 10 Extended- Merck Sharp & Chloride. milliequivalen Release Dohme, Corp. ts (meq); 20 Tablet; Oral. meq. ANDA 060572.......... MYCOLOG-II........... Nystatin; 100,000 units/ Ointment; Delcor Asset Triamcinolone gram; 0.1%. Topical. Corp. Acetonide. ANDA 084343.......... KENALOG.............. Triamcinolone 0.025%; 0.1%... Lotion; Topical Delcor Asset Acetonide. Corp. ---------------------------------------------------------------------------------------------------------------- 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: May 31, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-13181 Filed 6-3-16; 8:45 am] BILLING CODE 4164-01-P
![36312 Federal Register / Vol. 81, No. 108 / Monday, June 6, 2016 / Notices
known, distribution, disposition, or there are an estimated 29,799 deceased collection burden is for the general
expiration of the tissue, whichever is donors of conventional tissue and review and update of written
the latest. Section 1270.35(a) through (d) 70,027 deceased donors of eye tissue procedures estimated to take an annual
requires specific records to be each year. average of 24 hours, and for the
maintained to document the following: Accredited members of the American recording and justifying of any
(1) The results and interpretation of all Association of Tissue Banks (AATB) deviations from the written procedures
required infectious disease tests; (2) and Eye Bank Association of America under § 1270.31(a) and (b), estimated to
information on the identity and relevant (EBAA) adhere to standards of those take an annual average of 1 hour. The
medical records of the donor; (3) the organizations that are comparable to the information collection burden for
receipt and/or distribution of human recordkeeping requirements in part maintaining records concurrently with
tissue, and (4) the destruction or other 1270. Based on information provided by the performance of each significant
disposition of human tissue. CBER’s database system, 90 percent of screening and testing step and for
Respondents to this collection of the conventional tissue banks are retaining records for 10 years under
information are manufacturers of human members of AATB (262 × 90% = 236), § 1270.33(a), (f), and (h) include
tissue intended for transplantation. and 95 percent of eye tissue banks are
documenting the results and
Based on information from the Center members of EBAA (121 × 95% = 115).
interpretation of all required infectious
for Biologics Evaluation and Research’s Therefore, recordkeeping by these 351
disease tests and results and the identity
(CBER’s) database system, FDA establishments (236 + 115 = 351) is
and relevant medical records of the
estimates that there are approximately excluded from the burden estimates as
383 tissue establishments of which 262 donor required under § 1270.35(a) and
usual and customary business activities
are conventional tissue banks and 121 (b). Therefore, the burden under these
(5 CFR 1320.3(b)(2)). The recordkeeping
are eye tissue banks. Based on provisions is calculated together in table
burden, thus, is estimated for the
information provided by industry, there 1 of this document. The recordkeeping
remaining 32 establishments, which is
are an estimated total of 2,141,960 8.36 percent of all establishments (383 estimates for the number of total annual
conventional tissue products and ¥ 351 = 32, or 32/383 = 8.36%). records and hours per record are based
130,987 eye tissue products distributed FDA assumes that all current tissue on information provided by industry
per year with an average of 25 percent establishments have developed written and FDA experience.
of the tissue discarded due to procedures in compliance with part FDA estimates the burden of this
unsuitability for transplant. In addition, 1270. Therefore, their information information collection as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
1270.31(a), (b), (c), and (d) 2 ............................................... 32 1 32 24 768
1270.31(a) and 1270.31(b) 3 ................................................ 32 2 64 1 64
1270.33(a), (f), and (h), and 1270.35(a) and (b) ................. 32 6,198.84 198,363 1.0 198,363
1270.35(c) ............................................................................ 32 11,876.12 380,036 1.0 380,036
1270.35(d) ............................................................................ 32 1,454.50 47,504 1.0 47,504
Total .............................................................................. ........................ ........................ ........................ ........................ 626,735
1 Thereare no capital costs or operating and maintenance costs associated with this collection of information.
2 Reviewand update of standard operating procedures (SOPs).
3 Documentation of deviations from SOPs.
Dated: May 27, 2016. SUMMARY: The Food and Drug SUPPLEMENTARY INFORMATION: In 1984,
Leslie Kux, Administration (FDA or Agency) has Congress enacted the Drug Price
Associate Commissioner for Policy. determined that the drug products listed Competition and Patent Term
[FR Doc. 2016–13224 Filed 6–3–16; 8:45 am] in this document were not withdrawn Restoration Act of 1984 (Pub. L. 98–417)
BILLING CODE 4164–01–P from sale for reasons of safety or (the 1984 amendments), which
effectiveness. This determination means authorized the approval of duplicate
that FDA will not begin procedures to versions of drug products approved
DEPARTMENT OF HEALTH AND withdraw approval of abbreviated new under an ANDA procedure. ANDA
HUMAN SERVICES drug applications (ANDAs) that refer to applicants must, with certain
these drug products, and it will allow exceptions, show that the drug for
Food and Drug Administration FDA to continue to approve ANDAs that which they are seeking approval
[Docket No. FDA–2016–N–1284] refer to the products as long as they contains the same active ingredient in
meet relevant legal and regulatory the same strength and dosage form as
Determination That APRESOLINE requirements. the ‘‘listed drug,’’ which is a version of
(Hydralazine Hydrochloride) Injectable the drug that was previously approved.
sradovich on DSK3TPTVN1PROD with NOTICES
and Other Drug Products Were Not FOR FURTHER INFORMATION CONTACT: ANDA applicants do not have to repeat
Withdrawn From Sale for Reasons of Stacy Kane, Center for Drug Evaluation the extensive clinical testing otherwise
Safety or Effectiveness and Research, Food and Drug necessary to gain approval of a new
Administration, 10903 New Hampshire drug application (NDA).
AGENCY: Food and Drug Administration,
HHS. Ave., Bldg. 51, Rm. 6236, Silver Spring, The 1984 amendments include what
MD 20993–0002, 301–796–8363, is now section 505(j)(7) of the Federal
ACTION: Notice.
Stacy.Kane@fda.hhs.gov. Food, Drug, and Cosmetic Act (21 U.S.C.
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![Federal Register / Vol. 81, No. 108 / Monday, June 6, 2016 / Notices 36313
355(j)(7)), which requires FDA to was withdrawn from sale for reasons of petitions for such a determination under
publish a list of all approved drugs. safety or effectiveness (21 CFR 314.162). 21 CFR 10.25(a) and 10.30. Section
FDA publishes this list as part of the Under § 314.161(a) (21 CFR 314.161(d) provides that if FDA
‘‘Approved Drug Products With 314.161(a)), the Agency must determine determines that a listed drug was
Therapeutic Equivalence Evaluations,’’ whether a listed drug was withdrawn withdrawn from sale for safety or
which is generally known as the from sale for reasons of safety or effectiveness reasons, the Agency will
‘‘Orange Book.’’ Under FDA regulations, effectiveness: (1) Before an ANDA that initiate proceedings that could result in
a drug is removed from the list if the refers to that listed drug may be the withdrawal of approval of the
Agency withdraws or suspends approved, (2) whenever a listed drug is ANDAs that refer to the listed drug.
approval of the drug’s NDA or ANDA voluntarily withdrawn from sale and FDA has become aware that the drug
for reasons of safety or effectiveness, or ANDAs that refer to the listed drug have products listed in the following table are
if FDA determines that the listed drug been approved, and (3) when a person no longer being marketed.
Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant
NDA 008303 .......... APRESOLINE ...... Hydralazine Hydrochloride; 20 milligrams (mg)/milliliter Injectable; Injection Tablet; Novartis Pharmaceuticals
10 mg; 25 mg; 50 mg; Oral. Corp.
100 mg.
NDA 017853 .......... PROVENTIL ......... Albuterol Sulfate .................. Equivalent to (EQ) 2 mg Tablet; Oral .......................... Schering-Plough Corp.
base; EQ 4 mg base.
NDA 019439 .......... K-Dur .................... Potassium Chloride ............. 10 milliequivalents (meq); 20 Extended-Release Tablet; Merck Sharp & Dohme,
meq. Oral. Corp.
ANDA 060572 ....... MYCOLOG–II ....... Nystatin; Triamcinolone 100,000 units/gram; 0.1% ... Ointment; Topical ................ Delcor Asset Corp.
Acetonide.
ANDA 084343 ....... KENALOG ............ Triamcinolone Acetonide ..... 0.025%; 0.1% ...................... Lotion; Topical ..................... Delcor Asset Corp.
FDA has reviewed its records and, DEPARTMENT OF HEALTH AND instructions for submitting comments.
under § 314.161, has determined that HUMAN SERVICES Comments submitted electronically,
the drug products listed in this including attachments, to http://
document were not withdrawn from Food and Drug Administration www.regulations.gov will be posted to
sale for reasons of safety or [Docket No. FDA–2016–D–0643] the docket unchanged. Because your
effectiveness. Accordingly, the Agency comment will be made public, you are
will continue to list the drug products Labeling for Biosimilar Products; Draft solely responsible for ensuring that your
listed in this document in the Guidance for Industry; Availability; comment does not include any
‘‘Discontinued Drug Product List’’ Extension of Comment Period confidential information that you or a
section of the Orange Book. The third party may not wish to be posted,
AGENCY: Food and Drug Administration, such as medical information, your or
‘‘Discontinued Drug Product List’’ HHS.
identifies, among other items, drug anyone else’s Social Security number, or
ACTION:Notice of availability; extension confidential business information, such
products that have been discontinued of comment period. as a manufacturing process. Please note
from marketing for reasons other than
that if you include your name, contact
safety or effectiveness. SUMMARY: The Food and Drug
information, or other information that
Approved ANDAs that refer to the Administration (FDA or Agency) is
identifies you in the body of your
NDAs and ANDAs listed in this extending the comment period for the
comments, that information will be
notice entitled ‘‘Labeling for Biosimilar
document are unaffected by the posted on http://www.regulations.gov.
Products; Draft Guidance for Industry;
discontinued marketing of the products
Availability’’ that appeared in the • If you want to submit a comment
subject to those NDAs and ANDAs. with confidential information that you
Federal Register of April 4, 2016. The
Additional ANDAs that refer to these Agency is taking this action to allow do not wish to be made available to the
products may also be approved by the interested persons additional time to public, submit the comment as a
Agency if they comply with relevant submit comments. written/paper submission and in the
legal and regulatory requirements. If manner detailed (see ‘‘Written/Paper
DATES: FDA is extending the comment
FDA determines that labeling for these Submissions’’ and ‘‘Instructions’’).
period for the notice that published on
drug products should be revised to meet April 4, 2016 (81 FR 19194) by an Written/Paper Submissions
current standards, the Agency will additional 60 days. Although you can
advise ANDA applicants to submit such comment on any guidance at any time Submit written/paper submissions as
labeling. (see 21 CFR 10.115(g)(5)), to permit the follows:
Dated: May 31, 2016. Agency to consider your comments • Mail/Hand delivery/Courier (for
before issuing the final version of the written/paper submissions): Division of
Leslie Kux,
guidance, submit either electronic or Dockets Management (HFA–305), Food
Associate Commissioner for Policy. and Drug Administration, 5630 Fishers
written comments on the draft guidance
[FR Doc. 2016–13181 Filed 6–3–16; 8:45 am] Lane, Rm. 1061, Rockville, MD 20852.
by August 2, 2016.
BILLING CODE 4164–01–P • For written/paper comments
sradovich on DSK3TPTVN1PROD with NOTICES
ADDRESSES: You may submit comments
as follows: submitted to the Division of Dockets
Management, FDA will post your
Electronic Submissions comment, as well as any attachments,
Submit electronic comments in the except for information submitted,
following way: marked and identified, as confidential,
• Federal eRulemaking Portal: http:// if submitted as detailed in
www.regulations.gov. Follow the ‘‘Instructions.’’
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Document Created: 2016-06-04 00:16:48
Document Modified: 2016-06-04 00:16:48
| 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 | 81 FR 36312 |
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