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84 FR 132 pgs. 32927-32928 - Apotex, Inc.; Withdrawal of Approval of 31 Abbreviated New Drug Applications

Type: NOTICEVolume: 84Number: 132Pages: 32927 - 32928
Docket number: [Docket No. FDA-2019-N-2338]
FR document: [FR Doc. 2019-14660 Filed 7-9-19; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version:  PDF Version
Pages: 32927, 32928

[top] page 32927

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Approval is withdrawn as of July 10, 2019.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, 2012 Tolterodine Tartrate 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, 2013 Rasagiline Mesylate 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 §?314.150(d) (21 CFR 314.150(d)).


[top] 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 §?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]

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