Janssen Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 16 New Drug Applications, 28950-28951 [2020-10367]

Download as PDF 28950 Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices the structure (including increasing transparency) and resources to ensure customer experience is a focal point for agency leadership. To support this, OMB Circular A–11 Section 280 established government-wide standards for mature customer experience organizations in government and measurement. To enable Federal programs to deliver the experience taxpayers deserve, they must undertake three general categories of activities: Conduct ongoing customer research, gather and share customer feedback, and test services and digital products. These data collection efforts may be either qualitative or quantitative in nature or may consist of mixed methods. Additionally, data may be collected via a variety of means, including but not limited to electronic or social media, direct or indirect observation (i.e., in person, video and audio collections), interviews, questionnaires, surveys, and focus groups. The Centers for Medicare and Medicaid Services (CMS) will limit its inquiries to data collections that solicit strictly voluntary opinions or responses. Steps will be taken to ensure anonymity of respondents in each activity covered by this request. The results of the data collected will be used to improve the delivery of Federal services and programs. It will include the creation of personas, customer journey maps, and reports and summaries of customer feedback data and user insights. It will also provide government-wide data on customer experience that can be displayed on performance.gov to help build transparency and accountability of Federal programs to the customers they serve. Dated: May 8, 2020. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2020–10282 Filed 5–13–20; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of 16 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. SUMMARY: Approval is withdrawn as of June 15, 2020. DATES: FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993–0002, 301– 796–3137. 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 § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. SUPPLEMENTARY INFORMATION: Food and Drug Administration [Docket No. FDA–2020–N–1117] Janssen Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 16 New Drug Applications AGENCY: Food and Drug Administration, HHS. Application No. Drug Applicant NDA 011529 .......... NDA 019579 .......... Parafon Forte DSC (chlorzoxazone), Caplets, 500 milligrams (mg). Ritalin-SR (methylphenidate hydrochloride (HCl)) ExtendedRelease Tablets, 20 mg. Depakene (valproic acid) Oral Solution, 250 mg/5 milliliter (mL). Terazol 7 (terconazole) Vaginal Cream, 0.4% ....................... NDA 020119 .......... Vumon (teniposide) Injection, 10 mg/mL ............................... NDA 020388 .......... NDA 020741 .......... Navelbine (vinorelbine tartrate) Injection, Equivalent to (EQ) 10 mg/mL base. Prandin (repaglinide) Tablets, 0.5 mg, 1.0 mg, and 2.0 mg .. NDA 020920 .......... Natrecor (nesiritide) Injection, 1.5 mg/vial ............................. NDA 021001 .......... Axert (almotriptan malate) Tablets, EQ 6.25 mg base and EQ 12.5 mg base. Tricor (fenofibrate) Tablets, 54 mg and 160 mg .................... Striant (testosterone buccal system) Extended-Release Tablets, 30 mg. Children’s ElixSure IB (ibuprofen) Oral Suspension, 100mg/ 5 mL. Janssen Pharmaceuticals, Inc., 1000 Route 202 South, P.O. Box 300, Raritan, NJ 08869. Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936. AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL 60064. Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd., Titusville, NJ 08560. HQ Specialty Pharma, 120 Route 17 North, Paramus, NJ 07652. Pierre Fabre Medicament c/o Pierre Fabre Pharmaceuticals, Inc., 8 Campus Dr., Suite 202, Parsippany, NJ 07054. Gemini Laboratories, LLC, 400 Crossing Blvd., 5th Floor, Bridgewater, NJ 08807. Scios, LLC, 1125 Trenton-Harbourton Rd., Titusville, NJ 08560. Janssen Pharmaceuticals, Inc. NDA 018029 .......... NDA 018082 .......... jbell on DSKJLSW7X2PROD with NOTICES CMS will collect this information by electronic means when possible, as well as by mail, fax, telephone, technical discussions, and in-person interviews. CMS may also utilize observational techniques to collect this information. Form Number: CMS–10710 (OMB control number: 0938-New); Frequency: Occasionally; Affected Public: Individuals or Households; Private Sector (business or other for-profits, notfor-profit institutions), State, Local or Tribal governments; Federal government; and Universities; Number of Respondents: 1,001,750; Number of Responses: Varied, dependent upon the data collection method used. The possible response time to complete a questionnaire or survey may be 3 minutes or up to 2 hours to participate in an interview.; Total Annual Hours: 51,175. (For questions regarding this collection contact Aaron Lartey at 410– 786–7866). NDA 021203 .......... NDA 021543 .......... NDA 021604 .......... VerDate Sep<11>2014 18:29 May 13, 2020 Jkt 250001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 AbbVie Inc. Auxilium Pharmaceuticals, Inc., 1400 Atwater Dr., Malvern, PA 19355. Moberg Pharma North America LLC, 7 East Frederick Place, Suite 100, Cedar Knolls, NJ 07927. E:\FR\FM\14MYN1.SGM 14MYN1 Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices Application No. Drug Applicant NDA 021611 .......... Opana (oxymorphone HCl) Tablets, 5mg and 10mg ............. NDA 022321 .......... Embeda (morphine sulfate and naltrexone HCl) ExtendedRelease Capsules, 20 mg/0.8 mg, 30 mg/1.2 mg, 50 mg/ 2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg, and 100 mg/4 mg. Abstral (fentanyl) Sublingual Tablets,100 micrograms (mcg), 200 mcg, 300 mcg, 400 mcg, 600 mcg, and 800 mcg. Monodox (doxycycline monohydrate) Capsules, EQ 50mg base, EQ 75mg base, and EQ 100mg base. Endo Pharmaceuticals, Inc., 1400 Atwater Dr., Malvern, PA 19355. Alpharma Pharmaceuticals, LLC, 235 East 42nd St., New York, NY 10017. NDA 022510 .......... NDA 050641 .......... Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of June 15, 2020. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. 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 June 15, 2020 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: May 11, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–10367 Filed 5–13–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0501] Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES 28951 VerDate Sep<11>2014 18:29 May 13, 2020 Jkt 250001 Sentynl Therapeutics, Inc., 420 Stevens Ave., Suite 200, Solana Beach, CA 92075. Aqua Pharmaceuticals, LLC, 707 Eagleview Blvd., Suite 200, Exton, PA 19341. to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA’s thirdparty disclosure and recordkeeping requirements for reportable food. DATES: Submit either electronic or written comments on the collection of information by July 13, 2020. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 13, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2009–N–0501 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you E:\FR\FM\14MYN1.SGM 14MYN1

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[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28950-28951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10367]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1117]


Janssen Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 
16 New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of 16 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 June 15, 2020.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.

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. 
Withdrawal of approval of an application or abbreviated application 
under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
     Application No.                Drug                 Applicant
------------------------------------------------------------------------
NDA 011529...............  Parafon Forte DSC       Janssen
                            (chlorzoxazone),        Pharmaceuticals,
                            Caplets, 500            Inc., 1000 Route 202
                            milligrams (mg).        South, P.O. Box 300,
                                                    Raritan, NJ 08869.
NDA 018029...............  Ritalin-SR              Novartis
                            (methylphenidate        Pharmaceuticals
                            hydrochloride (HCl))    Corp., 1 Health
                            Extended-Release        Plaza, East Hanover,
                            Tablets, 20 mg.         NJ 07936.
NDA 018082...............  Depakene (valproic      AbbVie Inc., 1 North
                            acid) Oral Solution,    Waukegan Rd., North
                            250 mg/5 milliliter     Chicago, IL 60064.
                            (mL).
NDA 019579...............  Terazol 7               Janssen
                            (terconazole) Vaginal   Pharmaceuticals,
                            Cream, 0.4%.            Inc., 1125 Trenton-
                                                    Harbourton Rd.,
                                                    Titusville, NJ
                                                    08560.
NDA 020119...............  Vumon (teniposide)      HQ Specialty Pharma,
                            Injection, 10 mg/mL.    120 Route 17 North,
                                                    Paramus, NJ 07652.
NDA 020388...............  Navelbine (vinorelbine  Pierre Fabre
                            tartrate) Injection,    Medicament c/o
                            Equivalent to (EQ) 10   Pierre Fabre
                            mg/mL base.             Pharmaceuticals,
                                                    Inc., 8 Campus Dr.,
                                                    Suite 202,
                                                    Parsippany, NJ
                                                    07054.
NDA 020741...............  Prandin (repaglinide)   Gemini Laboratories,
                            Tablets, 0.5 mg, 1.0    LLC, 400 Crossing
                            mg, and 2.0 mg.         Blvd., 5th Floor,
                                                    Bridgewater, NJ
                                                    08807.
NDA 020920...............  Natrecor (nesiritide)   Scios, LLC, 1125
                            Injection, 1.5 mg/      Trenton-Harbourton
                            vial.                   Rd., Titusville, NJ
                                                    08560.
NDA 021001...............  Axert (almotriptan      Janssen
                            malate) Tablets, EQ     Pharmaceuticals,
                            6.25 mg base and EQ     Inc.
                            12.5 mg base.
NDA 021203...............  Tricor (fenofibrate)    AbbVie Inc.
                            Tablets, 54 mg and
                            160 mg.
NDA 021543...............  Striant (testosterone   Auxilium
                            buccal system)          Pharmaceuticals,
                            Extended-Release        Inc., 1400 Atwater
                            Tablets, 30 mg.         Dr., Malvern, PA
                                                    19355.
NDA 021604...............  Children's ElixSure IB  Moberg Pharma North
                            (ibuprofen) Oral        America LLC, 7 East
                            Suspension, 100mg/5     Frederick Place,
                            mL.                     Suite 100, Cedar
                                                    Knolls, NJ 07927.

[[Page 28951]]

 
NDA 021611...............  Opana (oxymorphone      Endo Pharmaceuticals,
                            HCl) Tablets, 5mg and   Inc., 1400 Atwater
                            10mg.                   Dr., Malvern, PA
                                                    19355.
NDA 022321...............  Embeda (morphine        Alpharma
                            sulfate and             Pharmaceuticals,
                            naltrexone HCl)         LLC, 235 East 42nd
                            Extended-Release        St., New York, NY
                            Capsules, 20 mg/0.8     10017.
                            mg, 30 mg/1.2 mg, 50
                            mg/2 mg, 60 mg/2.4
                            mg, 80 mg/3.2 mg, and
                            100 mg/4 mg.
NDA 022510...............  Abstral (fentanyl)      Sentynl Therapeutics,
                            Sublingual              Inc., 420 Stevens
                            Tablets,100             Ave., Suite 200,
                            micrograms (mcg), 200   Solana Beach, CA
                            mcg, 300 mcg, 400       92075.
                            mcg, 600 mcg, and 800
                            mcg.
NDA 050641...............  Monodox (doxycycline    Aqua Pharmaceuticals,
                            monohydrate)            LLC, 707 Eagleview
                            Capsules, EQ 50mg       Blvd., Suite 200,
                            base, EQ 75mg base,     Exton, PA 19341.
                            and EQ 100mg base.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of June 
15, 2020. Approval of each entire application is withdrawn, including 
any strengths and dosage forms inadvertently missing from the table. 
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 June 15, 2020 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: May 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10367 Filed 5-13-20; 8:45 am]
BILLING CODE 4164-01-P
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