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Approval is withdrawn as of July 10, 2019.
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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.
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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:
|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)).
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.
[FR Doc. 2019-14660 Filed 7-9-19; 8:45 am]
BILLING CODE 4164-01-P