[Federal Register Volume 86, Number 220 (Thursday, November 18, 2021)]
[Notices]
[Page 64506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25111]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1195]
Discovery Therapeutics, LLC, et al.; Withdrawal of Approval of 18
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 18 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of December 20, 2021.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, [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 040619............... Methimazole Tablets, Discovery
15 milligrams (mg). Therapeutics, LLC,
2831 Deer Hound Way,
Palm Harbor, FL
34683.
ANDA 070254............... Naloxone Hospira, Inc., 275
Hydrochloride (HCl) North Field Dr.,
Injection, 0.4 mg/ Building H1, Lake
milliliters (mL). Forest, IL 60045.
ANDA 070586............... Bupivacaine HCl Do.
Injection, 0.25%.
ANDA 071850............... Morphine Sulfate Do.
Injection, 1 mg/mL.
ANDA 075220............... Desmopressin Acetate Do.
Injection, 0.004 mg/
mL.
ANDA 076498............... Tretinoin Cream, ZO Skin Health, Inc.,
0.05%. 9685 Research Dr.,
Irvine, CA 92618.
ANDA 077245............... Ciprofloxacin Hospira, Inc.
Injection, 200 mg/20
mL (10 mg/mL) and
400 mg/40 mL (10 mg/
mL).
ANDA 080409............... Lidocaine HCl Do.
Solution, 4%.
ANDA 087446............... Chloroprocaine HCl Do.
Injection, 3%.
ANDA 087447............... Chloroprocaine HCl Do.
Injection, 2%.
ANDA 201653............... Levocetirizine Sun Pharmaceutical
Dihydrochloride Industries, Inc.,
Tablets, 5 mg. U.S. Agent for Sun
Pharmaceutical
Industries Ltd., 270
Prospect Plains Rd.,
Cranbury, NJ 08512.
ANDA 202524............... Levetiracetam Rouses Point
Extended Release Pharmaceuticals,
Tablets, 500 mg and LLC, 11 Commerce
750 mg. Dr., Cranford, NJ
07016.
ANDA 202857............... Daptomycin Powder for Hospira, Inc.
Injection, 500 mg/
vial.
ANDA 203885............... Amiodarone HCl Do.
Injection, 50 mg/mL.
ANDA 207864............... Eptifibatide The WhiteOak Group,
Injection, 2 mg/mL LLC, U.S. Agent for
and 75 mg/100 mL. Hybio Pharmaceutical
Co., Ltd., 1629 K
St. NW, Suite 300,
Washington, DC
20006.
ANDA 209489............... Caspofungin Acetate Cipla USA, Inc., U.S.
Powder for Agent for Cipla
Injection, 50 mg/ Limited, 10
vial and 70 mg/vial. Independence Blvd.,
Suite 300, Warren,
NJ 07059.
ANDA 210283............... Clofarabine Hospira, Inc.
Injection, 20 mg/20
mL (1 mg/mL).
ANDA 210855............... Sodium Nitroprusside Cipla USA, Inc.
Injection, 25 mg/mL.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
December 20, 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 December 20, 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: November 12, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25111 Filed 11-17-21; 8:45 am]
BILLING CODE 4164-01-P