83_FR_64370 83 FR 64131 - Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications

83 FR 64131 - Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 239 (December 13, 2018)

Page Range64131-64132
FR Document2018-26947

The Food and Drug Administration (FDA or Agency) is withdrawing approval of nine abbreviated new drug applications (ANDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Federal Register, Volume 83 Issue 239 (Thursday, December 13, 2018) 
[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Notices]
[Pages 64131-64132]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26947]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4416]


Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of nine abbreviated new drug applications (ANDAs) 
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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of January 14, 2019.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, 
[email protected].

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 described 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
------------------------------------------------------------------------
ANDA 073079.....................  Loperamide          Allied Pharma,
                                   Hydrochloride       Inc., 20
                                   (HCl) Oral          Corrielle St.,
                                   Solution, 1         Fords, NJ 08863.
                                   milligram (mg)/5
                                   milliliters.
ANDA 076741.....................  Ibuprofen Tablets   LNK International,
                                   USP, 100 mg.        Inc., 145
                                                       Ricefield Ln.,
                                                       Hauppauge, NY
                                                       11788.
ANDA 080210.....................  Lidocaine           Belmora, LLC, 2231
                                   Ointment, 5%.       Crystal Dr.,
                                                       #1000, Arlington,
                                                       VA 22202.
ANDA 085497.....................  Phendimetrazine     Virtus
                                   Tartrate Tablets,   Pharmaceuticals,
                                   35 mg.              LLC, 2050 Cabot
                                                       Blvd. West, 2nd
                                                       Floor, Langhorne,
                                                       PA 19047.
ANDA 085695.....................  Phendimetrazine     Do.
                                   Tartrate
                                   Capsules, 35 mg.
ANDA 086365.....................  Phendimetrazine     Do.
                                   Tartrate Tablets,
                                   35 mg.
ANDA 086399.....................  Theolair            Medicis
                                   (theophylline)      Pharmaceutical
                                   Tablets, 125 mg     Corp., c/o
                                   and 250 mg.         Valeant
                                                       Pharmaceuticals
                                                       North America,
                                                       LLC, 400 Somerset
                                                       Corporate Blvd.,
                                                       Bridgewater, NJ
                                                       08807.
ANDA 087378.....................  Phendimetrazine     Virtus
                                   Tartrate Extended-  Pharmaceuticals,
                                   Release Capsules,   LLC.
                                   105 mg.
ANDA 202030.....................  Bromfenac Sodium    Amring
                                   Ophthalmic          Pharmaceuticals,
                                   Solution,           Inc., 1235
                                   Equivalent to       Westlakes Dr.,
                                   0.09% Acid.         Suite 205,
                                                       Berwyn, PA 19312.
------------------------------------------------------------------------


[[Page 64132]]

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
January 14, 2019. 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 January 14, 2019, 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: December 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26947 Filed 12-12-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices 64131 from sale, but must be made prior to § 314.161 that IC–GREEN (indocyanine DEPARTMENT OF HEALTH AND approving an ANDA that refers to the green for injection), 10 mg/vial, 40 mg/ HUMAN SERVICES listed drug (§ 314.161 (21 CFR 314.161)). vial, and 50 mg/vial, was not withdrawn FDA may not approve an ANDA that for reasons of safety or effectiveness. Food and Drug Administration does not refer to a listed drug. The petitioner has identified no data or IC–GREEN (indocyanine green for other information suggesting that IC– [Docket No. FDA–2018–N–4416] injection), 10 mg/vial, 25 mg/vial, 40 GREEN (indocyanine green for mg/vial, and 50 mg/vial, is the subject injection), 10 mg/vial, 40 mg/vial, and Allied Pharma, Inc., et al.; Withdrawal of NDA 011525, held by Akorn, Inc. IC– 50 mg/vial, was withdrawn for reasons of Approval of Nine Abbreviated New GREEN (indocyanine green for of safety or effectiveness. We have Drug Applications injection), 25 mg/vial and 50 mg/vial, carefully reviewed our files for records became conditionally effective on concerning the withdrawal of IC– AGENCY: Food and Drug Administration, February 2, 1959. IC–GREEN GREEN (indocyanine green for HHS. (indocyanine green for injection), 10 injection), 10 mg/vial, 40 mg/vial, and ACTION: Notice. mg/vial and 40 mg/vial, became 50 mg/vial from sale. We have also conditionally effective on March 20, independently evaluated relevant SUMMARY: The Food and Drug 1967. NDA 011525 was included in the literature and data for possible Administration (FDA or Agency) is Drug Efficacy Study Implementation postmarketing adverse events. We have withdrawing approval of nine review, (35 FR 12231 (July 30, 1970); 42 reviewed the available evidence and abbreviated new drug applications FR 31495 (June 21, 1977)) and the determined that these drug products (ANDAs) from multiple applicants. The application was approved on August 2, were not withdrawn from sale for applicants notified the Agency in 1989. IC–GREEN (indocyanine green for reasons of safety or effectiveness. writing that the drug products were no injection) is indicated for determining Accordingly, the Agency will longer marketed and requested that the cardiac output, hepatic function, and continue to list IC–GREEN (indocyanine approval of the applications be liver blood flow, and for ophthalmic green for injection), 10 mg/vial, 40 mg/ withdrawn. angiography. vial, and 50 mg/vial, in the IC–GREEN (indocyanine green for ‘‘Discontinued Drug Product List’’ DATES: Approval is withdrawn as of injection), 10 mg/vial, 40 mg/vial, and section of the Orange Book. The January 14, 2019. 50 mg/vial, is currently listed in the ‘‘Discontinued Drug Product List’’ FOR FURTHER INFORMATION CONTACT: ‘‘Discontinued Drug Product List’’ delineates, among other items, drug Trang Tran, Center for Drug Evaluation section of the Orange Book. products that have been discontinued and Research, Food and Drug Foley & Lardner LLP submitted a from marketing for reasons other than Administration, 10903 New Hampshire citizen petition dated May 3, 2018 safety or effectiveness. ANDAs that refer Ave., Bldg. 75, Rm. 1671, Silver Spring, (Docket No. FDA–2018–P–1734), under to IC–GREEN (indocyanine green for MD 20993–0002, 240–402–7945, 21 CFR 10.30, requesting that the injection), 10 mg/vial, 40 mg/vial, and Trang.Tran@fda.hhs.gov. Agency determine whether IC–GREEN 50 mg/vial, may be approved by the (indocyanine green for injection), 10 Agency as long as they meet all other SUPPLEMENTARY INFORMATION: The mg/vial, 40 mg/vial, and 50 mg/vial, legal and regulatory requirements for applicants listed in the table have was withdrawn from sale for reasons of the approval of ANDAs. If FDA informed FDA that these drug products safety or effectiveness. In 1987, IC– determines that labeling for this drug are no longer marketed and have GREEN (indocyanine green for product should be revised to meet requested that FDA withdraw approval injection), 10 mg/vial and 40 mg/vial current standards, the Agency will of the applications under the process were discontinued from marketing. In advise ANDA applicants to submit such described in § 314.150(c) (21 CFR 1996, Akorn, Inc. discontinued labeling. 314.150(c)). The applicants have also, marketing IC–GREEN (indocyanine by their requests, waived their Dated: December 10, 2018. opportunity for a hearing. Withdrawal green for injection), 50mg/vial. After considering the citizen petition Leslie Kux, of approval of an application or and reviewing Agency records, and Associate Commissioner for Policy. abbreviated application under based on the information we have at this [FR Doc. 2018–26975 Filed 12–12–18; 8:45 am] § 314.150(c) is without prejudice to time, FDA has determined under BILLING CODE 4164–01–P refiling. Application No. Drug Applicant ANDA 073079 ................................. Loperamide Hydrochloride (HCl) Oral Solution, 1 Allied Pharma, Inc., 20 Corrielle St., Fords, NJ milligram (mg)/5 milliliters. 08863. ANDA 076741 ................................. Ibuprofen Tablets USP, 100 mg ................................ LNK International, Inc., 145 Ricefield Ln., Hauppauge, NY 11788. ANDA 080210 ................................. Lidocaine Ointment, 5% ............................................ Belmora, LLC, 2231 Crystal Dr., #1000, Arlington, VA 22202. ANDA 085497 ................................. Phendimetrazine Tartrate Tablets, 35 mg ................. Virtus Pharmaceuticals, LLC, 2050 Cabot Blvd. West, 2nd Floor, Langhorne, PA 19047. ANDA 085695 ................................. Phendimetrazine Tartrate Capsules, 35 mg ............. Do. ANDA 086365 ................................. Phendimetrazine Tartrate Tablets, 35 mg ................. Do. amozie on DSK3GDR082PROD with NOTICES1 ANDA 086399 ................................. Theolair (theophylline) Tablets, 125 mg and 250 mg Medicis Pharmaceutical Corp., c/o Valeant Pharma- ceuticals North America, LLC, 400 Somerset Cor- porate Blvd., Bridgewater, NJ 08807. ANDA 087378 ................................. Phendimetrazine Tartrate Extended-Release Cap- Virtus Pharmaceuticals, LLC. sules, 105 mg. ANDA 202030 ................................. Bromfenac Sodium Ophthalmic Solution, Equivalent Amring Pharmaceuticals, Inc., 1235 Westlakes Dr., to 0.09% Acid. Suite 205, Berwyn, PA 19312. VerDate Sep<11>2014 17:12 Dec 12, 2018 Jkt 247001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\13DEN1.SGM 13DEN1

64132 Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices Therefore, approval of the ADDRESSES: You may submit either submission. You should submit two applications listed in the table, and all electronic or written comments on copies total. One copy will include the amendments and supplements thereto, Agency guidances at any time as information you claim to be confidential is hereby withdrawn as of January 14, follows: with a heading or cover note that states 2019. Introduction or delivery for ‘‘THIS DOCUMENT CONTAINS Electronic Submissions introduction into interstate commerce of CONFIDENTIAL INFORMATION.’’ The products without approved new drug Submit electronic comments in the Agency will review this copy, including applications violates section 301(a) and following way: the claimed confidential information, in (d) of the Federal Food, Drug, and • Federal eRulemaking Portal: its consideration of comments. The Cosmetic Act (21 U.S.C. 331(a) and (d)). https://www.regulations.gov. Follow the second copy, which will have the Drug products that are listed in the table instructions for submitting comments. claimed confidential information that are in inventory on January 14, Comments submitted electronically, redacted/blacked out, will be available 2019, may continue to be dispensed including attachments, to https:// for public viewing and posted on until the inventories have been depleted www.regulations.gov will be posted to https://www.regulations.gov. Submit or the drug products have reached their the docket unchanged. Because your both copies to the Dockets Management expiration dates or otherwise become comment will be made public, you are Staff. If you do not wish your name and violative, whichever occurs first. solely responsible for ensuring that your contact information to be made publicly comment does not include any available, you can provide this Dated: December 7, 2018. confidential information that you or a information on the cover sheet and not Leslie Kux, third party may not wish to be posted, Associate Commissioner for Policy. in the body of your comments and you such as medical information, your or must identify this information as [FR Doc. 2018–26947 Filed 12–12–18; 8:45 am] anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked BILLING CODE 4164–01–P confidential business information, such as ‘‘confidential’’ will not be disclosed as a manufacturing process. Please note except in accordance with 21 CFR 10.20 that if you include your name, contact DEPARTMENT OF HEALTH AND and other applicable disclosure law. For information, or other information that HUMAN SERVICES more information about FDA’s posting identifies you in the body of your of comments to public dockets, see 80 comments, that information will be Food and Drug Administration FR 56469, September 18, 2015, or access posted on https://www.regulations.gov. • If you want to submit a comment the information at: https://www.gpo.gov/ [Docket No. FDA–2018–D–3984] with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- do not wish to be made available to the 23389.pdf. Data Integrity and Compliance With public, submit the comment as a Docket: For access to the docket to Drug CGMP: Questions and Answers; written/paper submission and in the read background documents or the Guidance for Industry; Availability manner detailed (see ‘‘Written/Paper electronic and written/paper comments Submissions’’ and ‘‘Instructions’’). received, go to https:// AGENCY: Food and Drug Administration, www.regulations.gov and insert the HHS. Written/Paper Submissions docket number, found in brackets in the ACTION: Notice of availability. Submit written/paper submissions as heading of this document, into the follows: ‘‘Search’’ box and follow the prompts SUMMARY: The Food and Drug • Mail/Hand Delivery/Courier (for Administration (FDA or Agency) is and/or go to the Dockets Management written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, announcing the availability of a final Management Staff (HFA–305), Food and guidance for industry entitled ‘‘Data Rockville, MD 20852. Drug Administration, 5630 Fishers Integrity and Compliance With Drug You may submit comments on any Lane, Rm. 1061, Rockville, MD 20852. CGMP: Questions and Answers.’’ The guidance at any time (see 21 CFR • For written/paper comments purpose of the guidance is to clarify the 10.115(g)(5)). submitted to the Dockets Management role of data integrity in current good Staff, FDA will post your comment, as Submit written requests for single manufacturing practice (CGMP) for well as any attachments, except for copies of this guidance to the Division drugs. (Unless otherwise noted, the term information submitted, marked and of Drug Information, Center for Drug CGMP refers to CGMPs for drugs, identified, as confidential, if submitted Evaluation and Research, Food and including biologics.) The guidance has as detailed in ‘‘Instructions.’’ Drug Administration, 10001 New been developed in response to an Instructions: All submissions received Hampshire Ave., Hillandale Building, increase in findings of data integrity must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993– lapses in recent inspections. FDA 2018–D–3984 for ‘‘Data Integrity and 0002; the Office of Communication, expects that all data be reliable and Compliance With Drug CGMP: Outreach and Development, Center for accurate. CGMP regulations and Questions and Answers.’’ Received Biologics Evaluation and Research, guidance allow for flexible and risk- comments will be placed in the docket Food and Drug Administration, 10903 based strategies to prevent and detect and, except for those submitted as New Hampshire Ave., Bldg. 71, Rm. data integrity issues. Firms should ‘‘Confidential Submissions,’’ publicly 3128, Silver Spring, MD 20993–0002; or implement meaningful and effective viewable at https://www.regulations.gov the Policy and Regulations Staff (HFV– strategies to manage their data integrity or at the Dockets Management Staff 6), Center for Veterinary Medicine, Food amozie on DSK3GDR082PROD with NOTICES1 risks based on their process between 9 a.m. and 4 p.m., Monday and Drug Administration, 7500 Standish understanding and knowledge through Friday. Pl., Rockville, MD 20855. Send one self- management of technologies and • Confidential Submissions—To addressed adhesive label to assist that business models. submit a comment with confidential office in processing your requests. See DATES: The announcement of the information that you do not wish to be the SUPPLEMENTARY INFORMATION section guidance is published in the Federal made publicly available, submit your for electronic access to the guidance Register on December 13, 2018. comments only as a written/paper document. VerDate Sep<11>2014 17:12 Dec 12, 2018 Jkt 247001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\13DEN1.SGM 13DEN1


Document Created: 2018-12-13 01:16:10
Document Modified: 2018-12-13 01:16:10
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesApproval is withdrawn as of January 14, 2019.
ContactTrang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, [email protected]
FR Citation83 FR 64131 
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