Apotex, Inc.; Withdrawal of Approval of 31 Abbreviated New Drug Applications, 32927-32928 [2019-14660]

Download as PDF Federal Register / Vol. 84, No. 132 / Wednesday, July 10, 2019 / Notices April 16, 2019, Federal Register, 84 FR 15680, and amended May 23, 2019, Federal Register, 84 FR 23832, effective January 1, 2021. • The addition of instructions for MA–PDs to enter text in the free text field ‘‘why did we deny your request?’’ when they have determined that the requested drug being denied is covered under Part D. Form Number: CMS–10003 (OMB control number: 0938–0829); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 694; Total Annual Responses: 9,373,200; Total Annual Hours: 1,561,575. (For policy questions regarding this collection contact Staci Paige at 410–786–1943.) Dated: July 5, 2019. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2019–14719 Filed 7–9–19; 8:45 am] BILLING CODE 4120–01–P Food and Drug Administration [Docket No. FDA–2019–N–2338] Apotex, Inc.; Withdrawal of Approval of 31 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is jspears on DSK30JT082PROD with NOTICES 090419 090463 090499 090790 091260 091373 091379 200164 200832 200878 ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ April 22, 2009 ................................ August 30, 2010 ............................ April 22, 2009 ................................ October 6, 2010 ............................. August 25, 2011 ............................ April 22, 2011 ................................ November 6, 2012 ......................... September 25, 2012 ...................... October 15, 2012 ........................... April 20, 2012 ................................ 201294 ............................................ 201503 ............................................ 201505 ............................................ August 3, 2012 .............................. March 8, 2013 ............................... October 15, 2012 ........................... 201508 201950 202078 202079 202244 202476 202477 202884 ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ August 3, 2012 .............................. September 12, 2013 ...................... May 14, 2013 ................................. January 10, 2014 ........................... December 31, 2012 ....................... May 14, 2013 ................................. July 1, 2013 ................................... December 4, 2012 ......................... 203021 ............................................ 203026 ............................................ May 22, 2012 ................................. March 21, 2013 ............................. 205258 ............................................ April 3, 2014 .................................. Jkt 247001 Kristiana Brugger, Office of Regulatory Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262, Silver Spring, MD 20993, 301–796–3600. FDA approved the following ANDAs on the dates indicated in the table, for the conditions of use found in the reference listed drug for each application: SUPPLEMENTARY INFORMATION: Hydrochlorothiazide Tablets USP, 25 milligrams (mg) and 50 mg. Azithromycin Tablets, 250 mg. Azithromycin Tablets, 600 mg. Azithromycin Tablets, 500 mg. Hydrochlorothiazide Capsules, 12.5 mg. Donepezil Hydrochloride Tablets, 5 mg and 10 mg. Losartan Potassium and Hydrochlorothiazide Tablets, 50 mg/12.5 mg, 100 mg/12.5mg, and 100 mg/25 mg. Mycophenolate Mofetil Capsules, 250 mg. Perindopril Erbumine Tablets, 2 mg, 4 mg, and 8 mg. Mycophenolate Mofetil Tablets, 500 mg. Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg. Cevimeline Hydrochloride Capsules, 30 mg. Naratriptan Tablets USP, 1 mg and 2.5 mg. Sildenafil Citrate Tablets, 20 mg. Tolterodine Tartrate Tablets, 1 mg and 2 mg. Irbesartan Tablets USP, 75 mg, 150 mg, and 300 mg. Verapamil Hydrochloride Extended-Release Tablets USP, 120 mg, 180 mg, and 240 mg. Montelukast Sodium Tablets, 10 mg. Cabergoline Tablets, 0.5 mg. Irbesartan and Hydrochlorothiazide Tablets USP, 150 mg/12.5 mg, and 300 mg/12.5 mg. Montelukast Sodium Chewable Tablets, 4 mg and 5 mg. Rasagiline Mesylate Tablets, 0.5 mg and 1 mg. Zolmitriptan Tablets, 2.5 mg and 5 mg. Candesartan Cilexetil Tablets, 4 mg, 8 mg, 16 mg, and 32 mg. Rizatriptan Benzoate Tablets, 5 mg and 10 mg. Zolmitriptan Orally Disintegrating Tablets, 2.5 mg and 5 mg. Rizatriptan Benzoate Orally Disintegrating Tablets, 5 mg and 10 mg. Candesartan Cilexetil and Hydrochlorothiazide Tablets, 16 mg/12.5 mg, 32 mg/12.5 mg, and 32 mg/25 mg. Nevirapine Tablets USP, 200 mg. Valsartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg. Nevirapine Extended-Release Tablets, 400 mg. October 3, 2007 ............................. July 13, 2011 ................................. July 13, 2011 ................................. July 13, 2011 ................................. May 16, 2008 ................................. June 2, 2011 .................................. October 6, 2010 ............................. 18:32 Jul 09, 2019 FOR FURTHER INFORMATION CONTACT: Name of drug product ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ VerDate Sep<11>2014 Approval is withdrawn as of July 10, 2019. Date of approval 040774 065507 065508 065509 078389 078841 090150 However, after these drugs were approved, FDA became aware of concerns involving material manufactured at two Apotex facilities, at least one of which was named in each of these applications. The facilities involved were Apotex Private Research withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex, Inc. (Apotex). Apotex, through its U.S. agent, has requested withdrawal of these applications and has waived its opportunity for a hearing. DATES: DEPARTMENT OF HEALTH AND HUMAN SERVICES SUMMARY: ANDA 32927 Ltd. (Federal Employer Identification (FEI) number: 3006076314) and Apotex Pharmachem India Private Ltd. (FEI: 3005466325). The application numbers for the impacted ANDAs are listed above. In January 2018, Apotex requested withdrawal of the above PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 ANDAs and waived its opportunity for a hearing. FDA interprets this withdrawal request as a request under § 314.150(d) (21 CFR 314.150(d)). Therefore, for the reasons discussed above, and pursuant to Apotex’s request, FDA is withdrawing approval E:\FR\FM\10JYN1.SGM 10JYN1 32928 Federal Register / Vol. 84, No. 132 / Wednesday, July 10, 2019 / Notices of the ANDAs in the table above, and all amendments and supplements thereto, under § 314.150(d). In each case, approval of the entire application is withdrawn, including any approved strengths inadvertently missing from the table. Distribution of the products listed in the table above in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Dated: July 3, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–14660 Filed 7–9–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1747] Risk Evaluation and Mitigation Strategies: Modifications and Revisions; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Risk Evaluation and Mitigation Strategies: Modifications and Revisions.’’ This guidance provides information on how FDA will define and process submissions for modifications and revisions of risk evaluation and mitigation strategies (REMS), as well as information on what types of changes to approved REMS will be considered modifications or revisions of the REMS. The guidance also provides instructions to application holders related to procedures for submission of REMS modifications and revisions to FDA as well as different timeframes for FDA’s review of and action on such changes. The definitions of REMS modifications and revisions apply to all types of REMS. This guidance updates the guidance of the same name, issued April 7, 2015, including finalizing the portion that sets forth the submission procedures for REMS revisions. DATES: The announcement of the guidance is published in the Federal Register on July 10, 2019. ADDRESSES: You may submit either electronic or written comments on jspears on DSK30JT082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:32 Jul 09, 2019 Jkt 247001 Agency guidances at any time as follows: 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’’). 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– 2014–D–1747 for ‘‘Risk Evaluation and Mitigation Strategies: Modifications and Revisions.’’ Received comments 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 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 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 must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002, or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Vaishali Jarral, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6480, Silver Spring, MD 20993–0002, 301– 796–4248; or Stephen Ripley, Center for E:\FR\FM\10JYN1.SGM 10JYN1

Agencies

[Federal Register Volume 84, Number 132 (Wednesday, July 10, 2019)]
[Notices]
[Pages 32927-32928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14660]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2338]


Apotex, Inc.; Withdrawal of Approval of 31 Abbreviated New Drug 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing the approval of 31 abbreviated new drug applications 
(ANDAs) held by Apotex, Inc. (Apotex). Apotex, through its U.S. agent, 
has requested withdrawal of these applications and has waived its 
opportunity for a hearing.

DATES: Approval is withdrawn as of July 10, 2019.

FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Office of 
Regulatory Policy, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262, 
Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION: FDA approved the following ANDAs on the 
dates indicated in the table, for the conditions of use found in the 
reference listed drug for each application:

------------------------------------------------------------------------
             ANDA                Date of approval   Name of drug product
------------------------------------------------------------------------
040774........................  October 3, 2007..  Hydrochlorothiazide
                                                    Tablets USP, 25
                                                    milligrams (mg) and
                                                    50 mg.
065507........................  July 13, 2011....  Azithromycin Tablets,
                                                    250 mg.
065508........................  July 13, 2011....  Azithromycin Tablets,
                                                    600 mg.
065509........................  July 13, 2011....  Azithromycin Tablets,
                                                    500 mg.
078389........................  May 16, 2008.....  Hydrochlorothiazide
                                                    Capsules, 12.5 mg.
078841........................  June 2, 2011.....  Donepezil
                                                    Hydrochloride
                                                    Tablets, 5 mg and 10
                                                    mg.
090150........................  October 6, 2010..  Losartan Potassium
                                                    and
                                                    Hydrochlorothiazide
                                                    Tablets, 50 mg/12.5
                                                    mg, 100 mg/12.5mg,
                                                    and 100 mg/25 mg.
090419........................  April 22, 2009...  Mycophenolate Mofetil
                                                    Capsules, 250 mg.
090463........................  August 30, 2010..  Perindopril Erbumine
                                                    Tablets, 2 mg, 4 mg,
                                                    and 8 mg.
090499........................  April 22, 2009...  Mycophenolate Mofetil
                                                    Tablets, 500 mg.
090790........................  October 6, 2010..  Losartan Potassium
                                                    Tablets USP, 25 mg,
                                                    50 mg, and 100 mg.
091260........................  August 25, 2011..  Cevimeline
                                                    Hydrochloride
                                                    Capsules, 30 mg.
091373........................  April 22, 2011...  Naratriptan Tablets
                                                    USP, 1 mg and 2.5
                                                    mg.
091379........................  November 6, 2012.  Sildenafil Citrate
                                                    Tablets, 20 mg.
200164........................  September 25,      Tolterodine Tartrate
                                 2012.              Tablets, 1 mg and 2
                                                    mg.
200832........................  October 15, 2012.  Irbesartan Tablets
                                                    USP, 75 mg, 150 mg,
                                                    and 300 mg.
200878........................  April 20, 2012...  Verapamil
                                                    Hydrochloride
                                                    Extended-Release
                                                    Tablets USP, 120 mg,
                                                    180 mg, and 240 mg.
201294........................  August 3, 2012...  Montelukast Sodium
                                                    Tablets, 10 mg.
201503........................  March 8, 2013....  Cabergoline Tablets,
                                                    0.5 mg.
201505........................  October 15, 2012.  Irbesartan and
                                                    Hydrochlorothiazide
                                                    Tablets USP, 150 mg/
                                                    12.5 mg, and 300 mg/
                                                    12.5 mg.
201508........................  August 3, 2012...  Montelukast Sodium
                                                    Chewable Tablets, 4
                                                    mg and 5 mg.
201950........................  September 12,      Rasagiline Mesylate
                                 2013.              Tablets, 0.5 mg and
                                                    1 mg.
202078........................  May 14, 2013.....  Zolmitriptan Tablets,
                                                    2.5 mg and 5 mg.
202079........................  January 10, 2014.  Candesartan Cilexetil
                                                    Tablets, 4 mg, 8 mg,
                                                    16 mg, and 32 mg.
202244........................  December 31, 2012  Rizatriptan Benzoate
                                                    Tablets, 5 mg and 10
                                                    mg.
202476........................  May 14, 2013.....  Zolmitriptan Orally
                                                    Disintegrating
                                                    Tablets, 2.5 mg and
                                                    5 mg.
202477........................  July 1, 2013.....  Rizatriptan Benzoate
                                                    Orally
                                                    Disintegrating
                                                    Tablets, 5 mg and 10
                                                    mg.
202884........................  December 4, 2012.  Candesartan Cilexetil
                                                    and
                                                    Hydrochlorothiazide
                                                    Tablets, 16 mg/12.5
                                                    mg, 32 mg/12.5 mg,
                                                    and 32 mg/25 mg.
203021........................  May 22, 2012.....  Nevirapine Tablets
                                                    USP, 200 mg.
203026........................  March 21, 2013...  Valsartan and
                                                    Hydrochlorothiazide
                                                    Tablets USP, 80 mg/
                                                    12.5 mg, 160 mg/12.5
                                                    mg, 160 mg/25 mg,
                                                    320 mg/12.5 mg, and
                                                    320 mg/25 mg.
205258........................  April 3, 2014....  Nevirapine Extended-
                                                    Release Tablets, 400
                                                    mg.
------------------------------------------------------------------------

    However, after these drugs were approved, FDA became aware of 
concerns involving material manufactured at two Apotex facilities, at 
least one of which was named in each of these applications. The 
facilities involved were Apotex Private Research Ltd. (Federal Employer 
Identification (FEI) number: 3006076314) and Apotex Pharmachem India 
Private Ltd. (FEI: 3005466325). The application numbers for the 
impacted ANDAs are listed above. In January 2018, Apotex requested 
withdrawal of the above ANDAs and waived its opportunity for a hearing. 
FDA interprets this withdrawal request as a request under Sec.  
314.150(d) (21 CFR 314.150(d)).
    Therefore, for the reasons discussed above, and pursuant to 
Apotex's request, FDA is withdrawing approval

[[Page 32928]]

of the ANDAs in the table above, and all amendments and supplements 
thereto, under Sec.  314.150(d). In each case, approval of the entire 
application is withdrawn, including any approved strengths 
inadvertently missing from the table. Distribution of the products 
listed in the table above in interstate commerce without an approved 
application is illegal and subject to regulatory action (see sections 
505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(a) and 331(d)).

    Dated: July 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14660 Filed 7-9-19; 8:45 am]
 BILLING CODE 4164-01-P
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