Document ID: FDA-2019-N-2338-0001
Agency: fda
Document Type: Notice
Title: Apotex, Inc.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
Posted Date: 2019-07-10T04:00Z

[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.

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DATES: Approval is withdrawn as of July 10, 2019.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