[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DATES: Approval is withdrawn as of July 10, 2019.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:
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ANDA Date of approval Name of drug product
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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.
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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