Notice2021-13593
Watson Laboratories, Inc. et al.; Withdrawal of Approval of 36 Abbreviated New Drug Applications
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 25, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 36 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 120 (Friday, June 25, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33718-33719]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13593]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0492]
Watson Laboratories, Inc. et al.; Withdrawal of Approval of 36
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 36 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.
DATES: Approval is withdrawn as of July 26, 2021.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, <a href="/cdn-cgi/l/email-protection#236e4251574b420d6d44565a464d634547420d4b4b500d444c55"><span class="__cf_email__" data-cfemail="d895b9aaacb0b9f696bfada1bdb698bebcb9f6b0b0abf6bfb7ae">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec. 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 062142................. Doxycycline Hyclate Watson Laboratories,
Capsules, Inc. (an indirect,
Equivalent to (EQ) wholly owned
50 milligrams (mg) subsidiary of Teva
base and EQ 200 mg Pharmaceuticals
base. USA, Inc.), 400
Interpace Pkwy.,
Building A,
Parsippany, NJ
07054.
ANDA 062497................. Doxycycline Hyclate Teva Pharmaceuticals
Capsules, EQ 50 mg USA, Inc. 400
base and EQ 100 mg Interpace Pkwy.,
base. Building A,
Parsippany, NJ
07054.
ANDA 065152................. Cephalexin Capsules, Yung Shin
EQ 250 mg base and Pharmaceutical Ind.
EQ 500 mg base. Co. Ltd.,
authorized U.S.
agent, Carlsbad
Technology, Inc./
Simon Law, 5922
Farnsworth Ct.,
Suite 101,
Carlsbad, CA 92008.
ANDA 070550................. Propranolol Watson Laboratories,
Hydrochloride (HCl) Inc.
Tablets, 40 mg.
ANDA 070551................. Propranolol HCl Do.
Tablets, 80 mg.
ANDA 070943................. Oxazepam Capsules, IVAX Pharmaceuticals
10 mg. Inc. (an indirect
wholly owned
subsidiary of Teva
Pharmaceuticals
USA, Inc.), 400
Interpace Pkwy.,
Building A,
Parsippany, NJ
07054.
ANDA 070945................. Oxazepam Capsules, Do.
30 mg.
ANDA 071446................. Temazepam Capsules, Watson Laboratories,
15 mg. Inc.
ANDA 071447................. Temazepam Capsules, Do.
30 mg.
ANDA 072952................. Oxazepam Capsules, Do.
10 mg.
ANDA 073092................. Baclofen Tablets, 10 Do.
mg.
[[Page 33719]]
ANDA 074400................. Diflunisal Tablets, Do.
250 mg and 500 mg.
ANDA 074432................. Diclofenac Sodium Pliva, Inc. (an
Delayed Release indirect, wholly
Tablets, 50 mg and owned subsidiary of
75 mg. Teva
Pharmaceuticals
USA, Inc.), 400
Interpace Pkwy.,
Building A,
Parsippany, NJ
07054.
ANDA 074460................. Piroxicam Capsules, Watson Laboratories,
10 mg and 20 mg. Inc.
ANDA 074585................. Indapamide Tablets, Do.
1.25 mg and 2.5 mg.
ANDA 074698................. Baclofen Tablets, 10 Do.
mg and 20 mg.
ANDA 074711................. Mexiletine HCl Do.
Capsules, 150 mg,
200 mg and 250 mg.
ANDA 074723................. Diclofenac Sodium Teva Pharmaceuticals
Delayed Release USA, Inc.
Tablets, 50 mg.
ANDA 074852................. Diltiazem HCl Actavis Laboratories
Extended Release FL, Inc. (an
Capsules, 120 mg, indirect, wholly
180 mg, and 240 mg. owned subsidiary of
Teva
Pharmaceuticals
USA, Inc.), 400
Interpace Pkwy.,
Building A,
Parsippany, NJ
07054.
ANDA 074865................. Mexiletine HCl Watson Laboratories,
Capsules, 150 mg, Inc.
200 mg, and 250 mg.
ANDA 074870................. Acyclovir Tablets, Actavis Elizabeth
400 mg and 800 mg. LLC (an indirect,
wholly owned
subsidiary of Teva
Pharmaceuticals
USA, Inc.), 400
Interpace Pkwy.,
Building A,
Parsippany, NJ
07054.
ANDA 075101................. Acyclovir Capsules, Watson Laboratories,
200 mg. Inc.
ANDA 076022................. Fluoxetine HCl Carlsbad Technology,
Capsules, EQ 10 mg Inc., 5922
base and EQ 20 mg Farnsworth Ct.,
base. Carlsbad, CA 92008.
ANDA 078345................. Prednisolone Sodium Amneal
Phosphate Solution, Pharmaceuticals, 85
EQ 15 mg base/5 Adams Ave.,
milliliters (mL). Hauppauge, NY
11788.
ANDA 080521................. Isoniazid Tablets, Watson Laboratories,
300 mg. Inc.
ANDA 086537................. Nitroglycerin Lumara Health, Inc.,
Controlled-Release 1100 Winter St.,
Capsules, 6.5 mg. Suite 3000,
Waltham, MA 02451.
ANDA 086889................. Disulfiram Tablets, Watson Laboratories,
250 mg. Inc.
ANDA 086890................. Disulfiram Tablets, Watson Laboratories,
500 mg. Inc.
ANDA 087975................. Nitroglycerin Sandoz Inc., 100
Controlled-Release College Rd. West,
Capsules, 2.5 mg. Princeton, NJ
08540.
ANDA 087976................. Nitroglycerin Do.
Controlled-Release
Capsules, 6.5 mg.
ANDA 088509................. Nitroglycerin Do.
Controlled-Release
Capsules, 9 mg.
ANDA 090833................. Carbidopa/Levodopa Morton Grove
and Entacapone Pharmaceuticals
Tablets, 18.75 mg/ Inc./Wockhardt USA
200 mg/75 mg, 25 mg/ LLC., 6451 Main
200 mg/100 mg, St., Morton Grove,
31.25 mg/200 mg/125 IL 60053.
mg, 37.5 mg/200 mg/
150 mg, and 50 mg/
200 mg/200 mg.
ANDA 200771................. Irinotecan HCl Heritage
Injection, 40 mg/2 Pharmaceuticals
mL (20 mg/mL) and Inc. d/b/a/Avet
100 mg/5 mL (20 mg/ Pharmaceuticals
mL). Inc. U.S. Agent for
Emcure
Pharmaceuticals
Limited, One Tower
Center Blvd., East
Brunswick, NJ
08816.
ANDA 202063................. Gemcitabine HCl for Do.
Injection, EQ 200
mg base/vial; EQ 1
gram base/vial.
ANDA 204437................. Sodium Fluoride 18 UCSF
Injection, 10-200 Radiopharmaceutical
millicurie (mCi)/mL. Facility, 185 Berry
St., Suite 350, San
Francisco, CA
94107.
ANDA 208444................. Choline C-11 Do.
Injection, 4-33.1
mCi/mL.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of July
26, 2021. Approval of each entire application is withdrawn, including
any strengths and dosage forms inadvertently missing from the table.
Introduction or delivery for introduction into interstate commerce of
products without approved new drug applications violates section 301(a)
and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in the table that are in
inventory on July 26, 2021 may continue to be dispensed until the
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.
Dated: June 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13593 Filed 6-24-21; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on June 25, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.