[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48635-48636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20947]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3463]
Aurolife Pharma, LLC, et al.; Withdrawal of Approval of Seven
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 approval of seven 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of October 26, 2018.
FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945,
[email protected].
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.
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Application No. Drug Applicant
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ANDA 072112................. Clorazepate Aurolife Pharma,
Dipotassium LLC, 279 Princeton
Capsules, 3.75 Hightstown Rd.,
milligrams (mg), East Windsor, NJ
7.5 mg, and 15 mg. 08520.
ANDA 074863................. Clemastine Fumarate Workhardt Bio AG, c/
Syrup, Equivalent o Morton Grove
to (EQ) 0.5 mg base/ Pharmaceuticals,
5 milliliters (mL). Inc., 6451 Main
St., Morton Grove,
IL 60053.
ANDA 080925................. Isocaine 3% Septodont, Inc., c/o
(mepivacaine Arent Fox, LLP,
hydrochloride 1717 K St. NW,
(HCl)) Injection Washington, DC
USP, 3%. 20006.
ANDA 084048................. Octocaine (lidocaine Do.
HCl and
epinephrine)
Injection USP, 2%;
0.01 mg/mL and 2%;
0.02 mg/mL.
ANDA 084697................. Isocaine 2% Do.
(mepivacaine HCl
and levonordefrin)
Injection USP, 2%;
0.05 mg/mL.
ANDA 086033................. Isosorbide Dinitrate Watson Laboratories,
Sublingual Tablets Inc., Subsidiary of
USP, 2.5 mg. Teva
Pharmaceuticals
USA, Inc., 425
Privet Rd.,
Horsham, PA 19044.
ANDA 087504................. Chloroquine Teva Pharmaceuticals
Phosphate Tablets USA, Inc., 425
USP, EQ 150 mg base. Privet Rd.,
Horsham, PA 19044.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
October 26, 2018. Introduction or delivery for introduction into
interstate commerce of
[[Page 48636]]
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 October 26, 2018 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: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20947 Filed 9-25-18; 8:45 am]
BILLING CODE 4164-01-P