Skip to Content

During the funding lapse, Federalregister.gov is not being supported. If data feeds are not available from GPO, FederalRegister.gov will not be updated, so please use the official edition of the Federal Register on Govinfo (https://www.govinfo.gov/app/collection/fr). If there is a technical issue with the Public Inspection List, you can view the documents on public inspection at our office in Washington, DC or on archives.gov.

Notice

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

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document including its time on Public Inspection. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Enhanced Content

Relevant information about this document from Regulations.gov provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of January 14, 2019.

Start Further Info

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, Trang.Tran@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

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 § 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.

Application No.DrugApplicant
ANDA 073079Loperamide Hydrochloride (HCl) Oral Solution, 1 milligram (mg)/5 millilitersAllied Pharma, Inc., 20 Corrielle St., Fords, NJ 08863.
ANDA 076741Ibuprofen Tablets USP, 100 mgLNK International, Inc., 145 Ricefield Ln., Hauppauge, NY 11788.
ANDA 080210Lidocaine Ointment, 5%Belmora, LLC, 2231 Crystal Dr., #1000, Arlington, VA 22202.
ANDA 085497Phendimetrazine Tartrate Tablets, 35 mgVirtus Pharmaceuticals, LLC, 2050 Cabot Blvd. West, 2nd Floor, Langhorne, PA 19047.
ANDA 085695Phendimetrazine Tartrate Capsules, 35 mgDo.
ANDA 086365Phendimetrazine Tartrate Tablets, 35 mgDo.
ANDA 086399Theolair (theophylline) Tablets, 125 mg and 250 mgMedicis Pharmaceutical Corp., c/o Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
ANDA 087378Phendimetrazine Tartrate Extended-Release Capsules, 105 mgVirtus Pharmaceuticals, LLC.
ANDA 202030Bromfenac Sodium Ophthalmic Solution, Equivalent to 0.09% AcidAmring Pharmaceuticals, Inc., 1235 Westlakes Dr., Suite 205, Berwyn, PA 19312.
Start Printed 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.

Start Signature

Dated: December 7, 2018.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2018-26947 Filed 12-12-18; 8:45 am]

BILLING CODE 4164-01-P