83 FR 54355 - Endo Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 10 New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 209 (October 29, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 209 (October 29, 2018)
| Page Range | 54355-54356 | |
| FR Document | 2018-23528 |
[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)] [Notices] [Pages 54355-54356] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23528] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3647] Endo Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 10 New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of November 28, 2018. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601. SUPPLEMENTARY INFORMATION: The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. [[Page 54356]] Withdrawal of approval of an application or abbreviated application under Sec. 314.150(c) is without prejudice to refiling. ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ NDA 009165.............. Delatestryl Endo Pharmaceuticals, (testosterone Inc., 1400 Atwater enanthate) Injection, Dr., Malvern, PA 200 milligrams (mg)/ 19355. milliliter (mL). NDA 010417.............. Xylocaine (lidocaine Fresenius Kabi, USA, hydrochloride (HCl)) LLC, Three Corporate 4% Topical Solution/ Dr., Lake Zurich, IL Sterile Injection. 60047. NDA 016297.............. Xylocaine (1.5% Do. lidocaine HCl with dextrose 7.5%) Spinal Injection, 2 mL ampules. NDA 016724.............. Norinyl 1+80 GD Searle LLC, a (mestranol and subsidiary of Pfizer norethindrone) 21-Day Inc., 235 East 42nd Tablets, 0.08 mg/1 mg. St., New York, NY 10017. NDA 016725.............. Norinyl 1+80 Do. (mestranol and norethindrone) 28-Day Tablets, 0.08 mg/1 mg. NDA 019217.............. Sodium Chloride 0.9% ICU Medical, Inc., 600 Injection USP in N. Field Dr., Lake Plastic Container, 9 Forest, IL 60045. mg/mL. NDA 019222.............. Dextrose 5% Injection Do. USP in Plastic Container, 50 mg/mL. NDA 203098.............. Testosterone Gel, 2.5 Perrigo Co., U.S. mg/1.25 grams (g), 25 Agent for Perrigo mg/2.5 g, 50 mg/5 g. Israel Pharmaceuticals Ltd., 3490 Quebec Ave. North, Minneapolis, MN 55427. NDA 204031.............. Xartemis XR (oxycodone Mallinckrodt Inc., 675 HCl and McDonnell Blvd., acetaminophen) Hazelwood, MO 63042. Extended-Release Tablets, 7.5 mg/325 mg. NDA 205777.............. Targiniq ER (naloxone Purdue Pharma, LP, One HCl and oxycodone Stamford Forum, HCl) Extended-Release Stamford, CT 06901- Tablets, 5 mg/10 mg, 3431. 10 mg/20 mg, and 20 mg/40 mg. ------------------------------------------------------------------------ Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of November 28, 2018. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on November 28, 2018 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: October 23, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-23528 Filed 10-26-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices 54355
Description: This is a new proposed OCC will begin monitoring for of the complexity of each state’s CCDF
data collection from the Office of Child compliance in FY 2019. structure and variance in
Care (OCC) for the Onsite Monitoring The data collection for the first 3- implementation strategies. As a
System. years will focus on 11 topical areas: (1) response, OCC developed the
Section 658I of the Child Care and Disaster Preparedness, Response and Compliance Demonstration Packet that
Development Block Grant Act and Recovery; (2) Consumer Education: offers states the opportunity to propose
Subpart J of 45 CFR, part 98 of the Child Dissemination of Information to Parents, their approach to demonstrating
Care and Development Fund requires Providers, and General Public compliance based on how their CCDF
the monitoring of programs funded (Monitoring Reports and Annual program is administered. OCC also
under the CCDF for compliance with: Aggregate Data); (3) Twelve-Month consulted other federal programs and
(1) The Act; Eligibility; (4) Child: Staff Ratios and monitoring experts on the Onsite
Group Sizes; (5) Health and Safety Monitoring System’s development and
(2) CCDF Regulations; and Requirements for Providers (11 Health incorporated their feedback regarding
(3) The State/Territory CCDF and Safety Topics); (6) Pre-Service/ the efficiency and efficacy of the
approved Plan. Orientation and Ongoing Training proposed process.
The proposed data collection will be Requirements for Providers; (7)
used by the Office of Child Care (OCC) Inspections for CCDF Licensed During the development of the Onsite
to monitor State CCDF Lead Agencies to Providers; (8) Inspections for License- Monitoring System, OCC conducted
determine and validate compliance with Exempt CCDF Providers; (9) Ratios for pilots in a number of States. Feedback
CCDF regulations and the approved Licensing Inspectors; (10) Child Abuse received from pilot States and the pilot
State Plan. The data collection is and Neglect Reporting; and (11) Program results were used to enhance the
designed to provide States with the Integrity. monitoring process and data collection
flexibility to propose an approach that In developing the Onsite Monitoring method. Burden estimates below are
is feasible and sufficient to demonstrate System, OCC convened a workgroup of based on an analysis of data collected
compliance based on State states to provide feedback and input on through all of the pilot visits while
circumstances and processes. State Lead the design of the Onsite Monitoring accounting for variance in state
Agencies will participate in onsite System. As part of the workgroup documentation.
monitoring based on a 3-year cohort; discussions, states emphasized the need Respondents: State grantees and the
submitting data once every three years. for individualized monitoring because District of Columbia.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Compliance Demonstration Chart .................................................................... 17 1 16 272
Document Submission Chart ........................................................................... 17 1 80 1,360
Estimated Total Annual Burden the quality, utility, and clarity of the ACTION: Notice.
Hours: 1,632 hours. information to be collected; and (d)
In compliance with the requirements ways to minimize the burden of the SUMMARY: The Food and Drug
of the Paperwork Reduction Act of 1995 collection of information on Administration (FDA or Agency) is
(Pub. L. 104–13, 44 U.S.C. chap 35), the respondents, including through the use withdrawing approval of 10 new drug
Administration for Children and of automated collection techniques or applications (NDAs) from multiple
Families is soliciting public comment other forms of information technology. applicants. The applicants notified the
on the specific aspects of the Consideration will be given to Agency in writing that the drug
information collection described above. comments and suggestions submitted products were no longer marketed and
Copies of the proposed collection of within 60 days of this publication. requested that the approval of the
information can be obtained and applications be withdrawn.
Robert Sargis,
comments may be forwarded by writing DATES: Approval is withdrawn as of
Reports Clearance Officer. November 28, 2018.
to the Administration for Children and
[FR Doc. 2018–23536 Filed 10–26–18; 8:45 am]
Families, Office of Planning, Research FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4184–43–P
and Evaluation, 330 C Street SW, Florine P. Purdie, Center for Drug
Washington, DC 20201. Attn: ACF Evaluation and Research, Food and
Reports Clearance Officer. Email Drug Administration, 10903 New
DEPARTMENT OF HEALTH AND
address: infocollection@acf.hhs.gov. All Hampshire Ave., Bldg. 51, Rm. 6248,
HUMAN SERVICES
requests should be identified by the title Silver Spring, MD 20993–0002, 301–
of the information collection. Food and Drug Administration 796–3601.
The Department specifically requests SUPPLEMENTARY INFORMATION: The
comments on: (a) Whether the proposed applicants listed in the table have
amozie on DSK3GDR082PROD with NOTICES1
[Docket No. FDA–2018–N–3647]
collection of information is necessary informed FDA that these drug products
for the proper performance of the Endo Pharmaceuticals, Inc., et al.; are no longer marketed and have
functions of the agency, including Withdrawal of Approval of 10 New requested that FDA withdraw approval
whether the information shall have Drug Applications of the applications under the process in
practical utility; (b) the accuracy of the § 314.150(c) (21 CFR 314.150(c)). The
agency’s estimate of the burden of the AGENCY: Food and Drug Administration, applicants have also, by their requests,
proposed collection of information; (c) HHS. waived their opportunity for a hearing.
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![54356 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices
Withdrawal of approval of an under § 314.150(c) is without prejudice
application or abbreviated application to refiling.
Application No. Drug Applicant
NDA 009165 .......... Delatestryl (testosterone enanthate) Injection, 200 milli- Endo Pharmaceuticals, Inc., 1400 Atwater Dr., Malvern, PA
grams (mg)/milliliter (mL). 19355.
NDA 010417 .......... Xylocaine (lidocaine hydrochloride (HCl)) 4% Topical Solu- Fresenius Kabi, USA, LLC, Three Corporate Dr., Lake Zu-
tion/Sterile Injection. rich, IL 60047.
NDA 016297 .......... Xylocaine (1.5% lidocaine HCl with dextrose 7.5%) Spinal Do.
Injection, 2 mL ampules.
NDA 016724 .......... Norinyl 1+80 (mestranol and norethindrone) 21-Day Tablets, GD Searle LLC, a subsidiary of Pfizer Inc., 235 East 42nd
0.08 mg/1 mg. St., New York, NY 10017.
NDA 016725 .......... Norinyl 1+80 (mestranol and norethindrone) 28-Day Tablets, Do.
0.08 mg/1 mg.
NDA 019217 .......... Sodium Chloride 0.9% Injection USP in Plastic Container, 9 ICU Medical, Inc., 600 N. Field Dr., Lake Forest, IL 60045.
mg/mL.
NDA 019222 .......... Dextrose 5% Injection USP in Plastic Container, 50 mg/mL Do.
NDA 203098 .......... Testosterone Gel, 2.5 mg/1.25 grams (g), 25 mg/2.5 g, 50 Perrigo Co., U.S. Agent for Perrigo Israel Pharmaceuticals
mg/5 g. Ltd., 3490 Quebec Ave. North, Minneapolis, MN 55427.
NDA 204031 .......... Xartemis XR (oxycodone HCl and acetaminophen) Ex- Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO
tended-Release Tablets, 7.5 mg/325 mg. 63042.
NDA 205777 .......... Targiniq ER (naloxone HCl and oxycodone HCl) Extended- Purdue Pharma, LP, One Stamford Forum, Stamford, CT
Release Tablets, 5 mg/10 mg, 10 mg/20 mg, and 20 mg/ 06901–3431.
40 mg.
Therefore, approval of the announcing that a proposed collection generalizable scientific knowledge to
applications listed in the table, and all of information has been submitted to the help inform its implementation of
amendments and supplements thereto, Office of Management and Budget section 911 of the Federal Food, Drug,
is hereby withdrawn as of November 28, (OMB) for review and clearance under and Cosmetic Act (FD&C Act) (21 U.S.C.
2018. Introduction or delivery for the Paperwork Reduction Act of 1995. 387k), wherein FDA will be evaluating
introduction into interstate commerce of DATES: Fax written comments on the information submitted to the Agency
products without approved new drug collection of information by November about how consumers understand and
applications violates section 301(a) and 28, 2018. perceive modified risk tobacco products
(d) of the Federal Food, Drug, and ADDRESSES: To ensure that comments on (MRTPs). Section 911 of the FD&C Act
Cosmetic Act (21 U.S.C. 331(a) and (d)). the information collection are received, authorizes FDA to grant orders to
Drug products that are listed in the table OMB recommends that written persons to allow the marketing of
that are in inventory on November 28, comments be faxed to the Office of MRTPs. The term ‘‘modified risk
2018 may continue to be dispensed Information and Regulatory Affairs, tobacco product’’ means any tobacco
until the inventories have been depleted OMB, Attn: FDA Desk Officer, Fax: 202– product that is sold or distributed for
or the drug products have reached their 395–7285, or emailed to oira_ use to reduce harm or the risk of
expiration dates or otherwise become submission@omb.eop.gov. All tobacco-related disease associated with
violative, whichever occurs first. comments should be identified with the commercially marketed tobacco
Dated: October 23, 2018. OMB control number 0910–NEW and products. FDA can issue a risk
Leslie Kux, title ‘‘Investigation of Consumer modification order under section
Associate Commissioner for Policy.
Perceptions of Expressed Modified Risk 911(g)(1) of the FD&C Act authorizing
Claims.’’ Also include the FDA docket the marketing of an MRTP only if the
[FR Doc. 2018–23528 Filed 10–26–18; 8:45 am]
number found in brackets in the Agency determines that the product, as
BILLING CODE 4164–01–P
heading of this document. it is used by consumers, will
FOR FURTHER INFORMATION CONTACT: significantly reduce harm and the risk of
DEPARTMENT OF HEALTH AND Amber Sanford, Office of Operations, tobacco-related disease to individual
HUMAN SERVICES Food and Drug Administration, Three tobacco users and benefit the health of
White Flint North, 10A–12M, 11601 the population as a whole, taking into
Food and Drug Administration Landsdown St., North Bethesda, MD account both users of tobacco products
20852, 301–796–8867, PRAStaff@ and persons who do not currently use
[Docket No. FDA–2018–N–0821] fda.hhs.gov. tobacco products (section 911(g)(1) of
SUPPLEMENTARY INFORMATION: In the FD&C Act). Alternatively, with
Agency Information Collection
compliance with 44 U.S.C. 3507, FDA respect to tobacco products that may not
Activities; Submission for Office of
has submitted the following proposed be commercially marketed under
Management and Budget Review;
collection of information to OMB for section 911(g)(1) of the FD&C Act, FDA
Comment Request; Investigation of
review and clearance. may issue an exposure modification
Consumer Perceptions of Expressed
order under section 911(g)(2) of the
amozie on DSK3GDR082PROD with NOTICES1
Modified Risk Claims Investigation of Consumer Perceptions FD&C Act authorizing the marketing of
AGENCY: Food and Drug Administration, of Expressed Modified Risk Claims an MRTP if the Agency determines that
HHS. OMB Control Number 0910—NEW the standard in section 911(g)(2) of the
ACTION: Notice. FD&C Act is met, including, among
I. Background other requirements, that: Any aspect of
SUMMARY: The Food and Drug FDA’s Center for Tobacco Products the label, labeling, or advertising that
Administration (FDA, Agency, or we) is proposes to conduct a study to develop would cause the product to be an MRTP
VerDate Sep<11>2014 17:48 Oct 26, 2018 Jkt 247001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\29OCN1.SGM 29OCN1](https://thefederalregister.org/doc/83_FR_54564/page/2.svg)
Document Created: 2018-10-27 01:09:38
Document Modified: 2018-10-27 01:09:38
| 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. | |
| Dates | Approval is withdrawn as of November 28, 2018. | |
| Contact | Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601. | |
| FR Citation | 83 FR 54355 |
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