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

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Food and Drug Administration, HHS.




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.


Approval is withdrawn as of July 10, 2019.

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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.

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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:

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

Therefore, for the reasons discussed above, and pursuant to Apotex's request, FDA is withdrawing approval Start Printed Page 32928of 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)).

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Dated: July 3, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2019-14660 Filed 7-9-19; 8:45 am]