81 FR 52440 - Determination That BENTYL (Dicyclomine Hydrochloride) Syrup and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 152 (August 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 152 (August 8, 2016)
| Page Range | 52440-52441 | |
| FR Document | 2016-18707 |
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)] [Notices] [Pages 52440-52441] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18707] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2062] Determination That BENTYL (Dicyclomine Hydrochloride) Syrup and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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. 6207, 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 [[Page 52441]] 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 name Active ingredient(s) Strength(s) Dosage form/route Applicant -------------------------------------------------------------------------------------------------------------------------------------------------------- NDA 007961....................... BENTYL.............. Dicyclomine 10 milligrams (mg)/5 Syrup; Oral......... Aptalis Pharma US, Inc. Hydrochloride (HCl). milliliters (mL). NDA 011721....................... NEPTAZANE........... Methazolamide....... 25 mg; 50 mg............. Tablet; Oral........ Lederle Laboratories. NDA 016418....................... INDERAL............. Propranolol HCl..... 10 mg; 20 mg; 40 mg; 60 Tablet; Oral........ Wyeth Pharmaceuticals, mg. Inc., a subsidiary of Pfizer Inc. NDA 021410....................... AVANDAMET........... Metformin HCl; 500 mg/Equivalent to (EQ) Tablet; Oral........ SmithKline Beecham Rosiglitazone 2 mg base; 500 mg/EQ 4 (Cork) Ltd, Ireland. Maleate. mg base; 1 g/EQ 2 mg base; 1 g/EQ 4 mg base. NDA 021494....................... AXID................ Nizatidine.......... 15 mg/mL................. Solution; Oral...... Braintree Laboratories, Inc. NDA 050505....................... GARAMYCIN........... Gentamicin Sulfate.. EQ 2 mg base/mL.......... Injectable; Schering-Plough Corp. Intrathecal. ANDA 061716...................... GARAMYCIN........... Gentamicin Sulfate.. EQ 1 mg base/mL; EQ 40 mg Injectable; Schering-Plough Corp. base/mL. Injection. ANDA 061739...................... GARAMYCIN........... Gentamicin Sulfate.. EQ 10 mg base/mL......... Injectable; Schering-Plough Corp. Injection. ANDA 080745...................... ARISTOCORT and Triamcinolone 0.5%..................... Ointment; Topical... Astellas Pharma US, Inc. ARISTOCORT A. Acetonide. ANDA 083944...................... KENALOG............. Triamcinolone 0.5%..................... Ointment; Topical... Delcor Asset Corp. Acetonide. -------------------------------------------------------------------------------------------------------------------------------------------------------- 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: August 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-18707 Filed 8-5-16; 8:45 am] BILLING CODE 4164-01-P
![52440 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
(OMB) for review and clearance under SUPPLEMENTARY INFORMATION: In surveys being misrouted within the
the Paperwork Reduction Act of 1995. compliance with 44 U.S.C. 3507, FDA Agency mail system. The information
DATES: Fax written comments on the has submitted the following proposed gathered by the survey will be used to
collection of information by September collection of information to OMB for gain insights into, and to document,
7, 2016. review and clearance. impacts that the CFP has had and is
ADDRESSES: To ensure that comments on Survey of Alumni Commissioner’s having on former CFP fellows and
the information collection are received, Fellowship Program Fellows—OMB contributions and impacts that the
OMB recommends that written Control Number 0910–NEW former fellows are making in their
comments be faxed to the Office of current work. The surveys include
FDA is requesting approval from the questions to assess the following
Information and Regulatory Affairs, Office of Management and Budget to
OMB, Attn: FDA Desk Officer, FAX: measures: Post-fellowship employment
gather information from Alumni (e.g., employment type); number of
202–395–7285, or emailed to oira_ Commissioner’s Fellowship Program
submission@omb.eop.gov. All awards; number of contributions while
(CFP) Fellows. The information from a CFP fellow (e.g., number of
comments should be identified with the Alumni CFP Fellows will allow FDA’s
title Outcomes Evaluation Survey for publications, guidances authored or co-
Office of the Commissioner (OC) to authored); and contributions in their
Graduates of the FDA Commissioner’s easily and efficiently elicit and review
Fellowship Program. Also include the field (e.g., list of publications).
program feedback. The online survey
FDA docket number found in brackets will assist the Agency in promoting and In the Federal Register of February
in the heading of this document. protecting the public health by 24, 2016 (81 FR 9202), FDA published
FOR FURTHER INFORMATION CONTACT: FDA encouraging outside persons to share a 60-day notice requesting public
PRA Staff, Office of Operations, Food their experience with the FDA while a comment on the proposed collection of
and Drug Administration, 8455 Commissioner’s Fellow. The process information. No comments were
Colesville Rd., COLE–14526, Silver will reduce the time and cost of received.
Spring, MD 20993–0002, PRAStaff@ submitting written documentation to the FDA estimates the burden of this
fda.hhs.gov. Agency and lessen the likelihood of collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
Activity responses per Total hours
respondents responses response
respondent
Fellowship Program Survey ..................................... 35 1 35 0.50 (30 minutes) ...... 17.5
1 There are no capital costs or operating maintenance costs associated with this collection of information.
FDA based these estimates on the effectiveness. This determination means ANDA applicants do not have to repeat
number of fellows that have graduated that FDA will not begin procedures to the extensive clinical testing otherwise
and left the Agency over the past 5 withdraw approval of abbreviated new necessary to gain approval of a new
years. drug applications (ANDAs) that refer to drug application (NDA).
Dated: August 2, 2016. these drug products, and it will allow The 1984 amendments include what
Leslie Kux,
FDA to continue to approve ANDAs that is now section 505(j)(7) of the Federal
refer to the products as long as they Food, Drug, and Cosmetic Act (21 U.S.C.
Associate Commissioner for Policy.
meet relevant legal and regulatory 355(j)(7)), which requires FDA to
[FR Doc. 2016–18711 Filed 8–5–16; 8:45 am]
requirements. publish a list of all approved drugs.
BILLING CODE 4164–01–P
FDA publishes this list as part of the
FOR FURTHER INFORMATION CONTACT:
‘‘Approved Drug Products With
Stacy Kane, Center for Drug Evaluation
DEPARTMENT OF HEALTH AND Therapeutic Equivalence Evaluations,’’
and Research, Food and Drug
HUMAN SERVICES which is generally known as the
Administration, 10903 New Hampshire
‘‘Orange Book.’’ Under FDA regulations,
Ave., Bldg. 51, Rm. 6207, Silver Spring,
Food and Drug Administration a drug is removed from the list if the
MD 20993–0002, 301–796–8363,
Agency withdraws or suspends
[Docket No. FDA–2016–N–2062] Stacy.Kane@fda.hhs.gov.
approval of the drug’s NDA or ANDA
SUPPLEMENTARY INFORMATION: In 1984, for reasons of safety or effectiveness, or
Determination That BENTYL if FDA determines that the listed drug
Congress enacted the Drug Price
(Dicyclomine Hydrochloride) Syrup was withdrawn from sale for reasons of
Competition and Patent Term
and Other Drug Products Were Not safety or effectiveness (21 CFR 314.162).
Restoration Act of 1984 (Pub. L. 98–417)
Withdrawn From Sale for Reasons of
(the 1984 amendments), which Under § 314.161(a) (21 CFR
Safety or Effectiveness
authorized the approval of duplicate 314.161(a)), the Agency must determine
AGENCY: Food and Drug Administration, versions of drug products approved whether a listed drug was withdrawn
HHS. under an ANDA procedure. ANDA from sale for reasons of safety or
mstockstill on DSK3G9T082PROD with NOTICES
ACTION: Notice. applicants must, with certain effectiveness: (1) Before an ANDA that
exceptions, show that the drug for refers to that listed drug may be
SUMMARY: The Food and Drug which they are seeking approval approved, (2) whenever a listed drug is
Administration (FDA or Agency) has contains the same active ingredient in voluntarily withdrawn from sale and
determined that the drug products listed the same strength and dosage form as ANDAs that refer to the listed drug have
in this document were not withdrawn the ‘‘listed drug,’’ which is a version of been approved, and (3) when a person
from sale for reasons of safety or the drug that was previously approved. petitions for such a determination under
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![Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices 52441
21 CFR 10.25(a) and 10.30. Section effectiveness reasons, the Agency will FDA has become aware that the drug
314.161(d) provides that if FDA initiate proceedings that could result in products listed in the table in this
determines that a listed drug was the withdrawal of approval of the document are no longer being marketed.
withdrawn from sale for safety or ANDAs that refer to the listed drug.
Active ingre- Dosage form/
Application No. Drug name Strength(s) Applicant
dient(s) route
NDA 007961 ....... BENTYL ........... Dicyclomine Hy- 10 milligrams (mg)/5 milliliters Syrup; Oral ....... Aptalis Pharma US, Inc.
drochloride (mL).
(HCl).
NDA 011721 ....... NEPTAZANE ... Methazolamide 25 mg; 50 mg ............................. Tablet; Oral ...... Lederle Laboratories.
NDA 016418 ....... INDERAL ......... Propranolol HCl 10 mg; 20 mg; 40 mg; 60 mg .... Tablet; Oral ...... Wyeth Pharmaceuticals, Inc., a
subsidiary of Pfizer Inc.
NDA 021410 ....... AVANDAMET ... Metformin HCl; 500 mg/Equivalent to (EQ) 2 mg Tablet; Oral ...... SmithKline Beecham (Cork) Ltd,
Rosiglitazone base; 500 mg/EQ 4 mg base; Ireland.
Maleate. 1 g/EQ 2 mg base; 1 g/EQ 4
mg base.
NDA 021494 ....... AXID ................. Nizatidine ......... 15 mg/mL ................................... Solution; Oral ... Braintree Laboratories, Inc.
NDA 050505 ....... GARAMYCIN ... Gentamicin Sul- EQ 2 mg base/mL ...................... Injectable; Schering-Plough Corp.
fate. Intrathecal.
ANDA 061716 .... GARAMYCIN ... Gentamicin Sul- EQ 1 mg base/mL; EQ 40 mg Injectable; Injec- Schering-Plough Corp.
fate. base/mL. tion.
ANDA 061739 .... GARAMYCIN ... Gentamicin Sul- EQ 10 mg base/mL .................... Injectable; Injec- Schering-Plough Corp.
fate. tion.
ANDA 080745 .... ARISTOCORT Triamcinolone 0.5% ........................................... Ointment; Top- Astellas Pharma US, Inc.
and Acetonide. ical.
ARISTOCOR-
T A.
ANDA 083944 .... KENALOG ........ Triamcinolone 0.5% ........................................... Ointment; Top- Delcor Asset Corp.
Acetonide. ical.
FDA has reviewed its records and, DEPARTMENT OF HEALTH AND ADDRESSES: You may submit comments
under § 314.161, has determined that HUMAN SERVICES as follows:
the drug products listed in this Electronic Submissions
document were not withdrawn from Food and Drug Administration
sale for reasons of safety or Submit electronic comments in the
[Docket No. FDA–2011–D–0453]
effectiveness. Accordingly, the Agency following way:
will continue to list the drug products Deciding When To Submit a 510(k) for • Federal eRulemaking Portal: http://
listed in this document in the a Software Change to an Existing www.regulations.gov. Follow the
Device; Draft Guidance for Industry instructions for submitting comments.
‘‘Discontinued Drug Product List’’
and Food and Drug Administration Comments submitted electronically,
section of the Orange Book. The
Staff; Availability including attachments, to http://
‘‘Discontinued Drug Product List’’ www.regulations.gov will be posted to
identifies, among other items, drug AGENCY: Food and Drug Administration, the docket unchanged. Because your
products that have been discontinued HHS. comment will be made public, you are
from marketing for reasons other than ACTION: Notice of availability. solely responsible for ensuring that your
safety or effectiveness. comment does not include any
Approved ANDAs that refer to the SUMMARY: The Food and Drug confidential information that you or a
NDAs and ANDAs listed in this Administration (FDA or Agency) is third party may not wish to be posted,
document are unaffected by the announcing the availability of the draft such as medical information, your or
guidance entitled ‘‘Deciding When to anyone else’s Social Security number, or
discontinued marketing of the products
Submit a 510(k) for a Software Change confidential business information, such
subject to those NDAs and ANDAs.
to an Existing Device.’’ FDA is issuing as a manufacturing process. Please note
Additional ANDAs that refer to these this draft guidance document to clarify
products may also be approved by the that if you include your name, contact
when a software change in a legally information, or other information that
Agency if they comply with relevant marketed medical device would require
legal and regulatory requirements. If identifies you in the body of your
that a manufacturer submit a premarket comments, that information will be
FDA determines that labeling for these notification (510(k)) to FDA. This draft posted on http://www.regulations.gov.
drug products should be revised to meet guidance is not final nor is it in effect • If you want to submit a comment
current standards, the Agency will at this time. with confidential information that you
advise ANDA applicants to submit such DATES: Although you can comment on do not wish to be made available to the
labeling. any guidance at any time (see 21 CFR
mstockstill on DSK3G9T082PROD with NOTICES
public, submit the comment as a
Dated: August 2, 2016. 10.115(g)(5)), to ensure that the Agency written/paper submission and in the
Leslie Kux, considers your comment of this draft manner detailed (see ‘‘Written/Paper
guidance before it begins work on the Submissions’’ and ‘‘Instructions’’).
Associate Commissioner for Policy.
final version of the guidance, submit
[FR Doc. 2016–18707 Filed 8–5–16; 8:45 am]
either electronic or written comments Written/Paper Submissions
BILLING CODE 4164–01–P on the draft guidance by November 7, Submit written/paper submissions as
2016. follows:
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Document Created: 2016-08-06 03:08:06
Document Modified: 2016-08-06 03:08:06
| 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. 6207, Silver Spring, MD 20993-0002, 301-796-8363, [email protected] | |
| FR Citation | 81 FR 52440 |
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