[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Notices]
[Pages 12942-12943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04175]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0516]
Mylan Pharmaceuticals Inc., et.al.; Withdrawal of Approval of 11
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 11 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of March 31, 2023.
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
[[Page 12943]]
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 075980................. Tramadol Mylan
Hydrochloride (HCl) Pharmaceuticals
Tablets, 50 Inc., 3711 Collins
milligrams (mg). Ferry Rd.,
Morgantown, WV
26505.
ANDA 075986................. Tramadol HCl Do.
Tablets, 50 mg.
ANDA 201510................. Pirmella 7/7/7 Lupin
Tablets, 0.035 mg, Pharmaceuticals,
0.035 mg, 0.035 mg; Inc., U.S. Agent
0.5 mg, 0.75 mg, 1 for Lupin Ltd., 111
mg. South Calvert St.,
Harborplace Tower,
21st Floor,
Baltimore, MD
21202.
ANDA 201512................. Pirmella 1/35 Do.
Tablets, 0.035 mg;
1 mg.
ANDA 203803................. Propafenone HCl, Mylan
Extended-Release Pharmaceuticals
Capsules, 225 mg, Inc.
325 mg, and 425 mg.
ANDA 203900................. Tacrolimus Hospira, A Pfizer
Injection, Company, 275 North
Equivalent to (EQ) Field Dr., Lake
5 mg base/ Forest, IL 60045.
milliliters (mL).
ANDA 203946................. Fludeoxyglucose F18 Essential Isotopes,
Injectable, 20-300 LLC, 1513 Research
millicurie (mCi)/mL. Park Dr., Columbia,
MO 65211.
ANDA 205923................. Caspofungin Acetate Xellia
Powder, 50 mg/vial, Pharmaceuticals
and 70 mg/vial. USA, LLC, U.S.
Agent for Xellia
Pharmaceuticals
ApS, 2150 East Lake
Cook Rd., Suite
1015, Buffalo
Grove, IL 60089.
ANDA 209571................. Darifenacin Xiromed, LLC., U.S.
Hydrobromide Agent for Xiromed
Extended-Release Pharma
Tablets, EQ 7.5 mg/ Espa[ntilde]a,
base and EQ 15 mg/ S.L., 180 Park
base. Ave., Suite 101,
Florham Park, NJ
07932.
ANDA 211972................. Zileuton Extended- Lupin
Release Tablets, Pharmaceuticals,
600 mg. Inc.
ANDA 213222................. Icatibant Acetate Glenmark
Injectable, EQ 30 Pharmaceuticals
mg base/3 mL (EQ 10 Inc., USA, U.S.
mg base/mL). Agent for Glenmark
Pharmaceuticals
Ltd., 750 Corporate
Dr., Mahwah, NJ
07430.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of March
31, 2023. 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 March 31, 2023 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: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04175 Filed 2-28-23; 8:45 am]
BILLING CODE 4164-01-P