Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications, 27128 [2019-12287]

Download as PDF 27128 Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices Dated: June 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. Notice. Food and Drug Administration The Food and Drug Administration (FDA or Agency) is withdrawing approval of six 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. [Docket No. FDA–2019–N–1740] DATES: [FR Doc. 2019–12298 Filed 6–10–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. Application No. SUMMARY: Approval is withdrawn as of July 11, 2019.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, 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. SUPPLEMENTARY INFORMATION: Applicant ANDA 070185 ......... Fluor-Op (fluorometholone) Ophthalmic Suspension, 0.1% ANDA 070858 ......... Trazodone Hydrochloride Tablets USP, 100 milligrams (mg) ANDA 076023 ......... ANDA 078167 ......... ANDA 088726 ......... Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg. Paclitaxel Injection USP, 6 mg/milliliter ................................. Chlorpropamide Tablets USP, 250 mg ................................. ANDA 089852 ......... Chlorzoxazone Tablets USP, 250 mg ................................... Dated: June 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–12287 Filed 6–10–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 MD 20993–0002, 240–402–7945, Trang.Tran@fda.hhs.gov. Drug Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of July 11, 2019. Approval of each entire application is withdrawn, including any strengths or products 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 July 11, 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. khammond on DSKBBV9HB2PROD with NOTICES ACTION: 17:36 Jun 10, 2019 Jkt 247001 Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936. Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. Teva Pharmaceuticals USA, Inc., 400 Interpace Pkwy., Bldg. A, Parsippany, NJ 07054. Sandoz, Inc., 100 College Rd. West, Princeton, NJ 08540. Aurolife Pharma, LLC, 279 Princeton Hightstown Rd., East Windsor, NJ 08520. Do. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2018–E–0068; FDA– 2018–E–0069; FDA–2018–E–0070; FDA– 2018–E–0071; and FDA–2018–E–0072] Determination of Regulatory Review Period for Purposes of Patent Extension; KISQALI AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KISQALI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claims that human drug product. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by August 12, 2019. Furthermore, any interested person may SUMMARY: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 9, 2019. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. 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 August 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 12, 2019. 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 E:\FR\FM\11JNN1.SGM 11JNN1

Agencies

[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Page 27128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12287]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1740]


Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of 
Six Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of six 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 July 11, 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 070185...............  Fluor-Op               Novartis
                             (fluorometholone)      Pharmaceuticals
                             Ophthalmic             Corp., One Health
                             Suspension, 0.1%.      Plaza, East Hanover,
                                                    NJ 07936.
ANDA 070858...............  Trazodone              Watson Laboratories,
                             Hydrochloride          Inc., Subsidiary of
                             Tablets USP, 100       Teva Pharmaceuticals
                             milligrams (mg).       USA, Inc., 425
                                                    Privet Rd., Horsham,
                                                    PA 19044.
ANDA 076023...............  Hydrocodone            Teva Pharmaceuticals
                             Bitartrate and         USA, Inc., 400
                             Ibuprofen Tablets,     Interpace Pkwy.,
                             7.5 mg/200 mg.         Bldg. A, Parsippany,
                                                    NJ 07054.
ANDA 078167...............  Paclitaxel Injection   Sandoz, Inc., 100
                             USP, 6 mg/milliliter.  College Rd. West,
                                                    Princeton, NJ 08540.
ANDA 088726...............  Chlorpropamide         Aurolife Pharma, LLC,
                             Tablets USP, 250 mg.   279 Princeton
                                                    Hightstown Rd., East
                                                    Windsor, NJ 08520.
ANDA 089852...............  Chlorzoxazone Tablets  Do.
                             USP, 250 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of July 
11, 2019. Approval of each entire application is withdrawn, including 
any strengths or products 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 July 11, 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: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12287 Filed 6-10-19; 8:45 am]
 BILLING CODE 4164-01-P