Document ID: FDA-2023-N-0516-0001
Agency: fda
Document Type: Notice
Title: Mylan Pharmaceuticals Inc., et.al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications
Posted Date: 2023-03-01T05:00Z

[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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of March 31, 2023.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.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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