[Federal Register Volume 89, Number 79 (Tuesday, April 23, 2024)]
[Notices]
[Pages 30379-30380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08657]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1786]
PAI Holdings, LLC DBA Pharmaceutical Associates, Inc., et al.;
Withdrawal of Approval of 23 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 23 new drug applications (NDAs) 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applications be withdrawn.
DATES: Approval is withdrawn as of May 23, 2024.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [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 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.
[[Page 30380]]
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Application No. Drug Applicant
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NDA 007959............. Tensilon (edrophonium PAI Holdings, LLC dba
chloride) Injection, Pharmaceutical
10 milligrams (mg)/ Associates, Inc.,
milliliter (mL). 1700 Perimeter Rd.,
Tensilon Preservative Greenville, SC 29605.
Free (edrophonium
chloride) Injection,
10 mg/mL.
NDA 009900............. Cortef (hydrocortisone Pharmacia and Upjohn
cypionate) Oral Co., 66 Hudson Blvd.
Suspension, Equivalent East, New York, NY
to (EQ) 10 mg base/5 10001.
mL.
NDA 015923............. Haldol (haloperidol Janssen
lactate) Injection, EQ Pharmaceuticals,
5 mg base/mL. Inc., 1000 U.S. Route
202, Raritan, NJ
08869.
NDA 017090............. Tofranil-PM (imipramine SpecGx LLC, 385
pamoate) Capsules, EQ Marshall Ave.,
75 mg hydrochloride Webster Groves, MO
(HCl), EQ 100 mg HCl, 63119.
EQ 125 mg HCl, and EQ
150 mg HCl.
NDA 018309............. Topicort LP Taro Pharmaceuticals
(desoximetasone) U.S.A., Inc., 3
Emollient Cream, 0.05%. Skyline Dr.,
Hawthorne, NY 10532.
NDA 018401............. Buprenex (buprenorphine Indivior Inc., 10710
HCl) Injection, EQ 0.3 Midlothian Turnpike,
mg base/mL. Suite 125, North
Chesterfield, VA
23235.
NDA 019201............. Voltaren (diclofenac Novartis
sodium) Delayed- Pharmaceuticals
Release Tablets, 25 Corp., 1 Health
mg, 50 mg, and 75 mg. Plaza, East Hanover,
NJ 07936.
NDA 019425............. Trandate (labetalol Sebela Ireland
HCl) Injection, 5 mg/ Limited, c/o Sebela
mL. Pharmaceuticals Inc.,
645 Hembree Pkwy.,
Suite 1, Roswell, GA
30076.
NDA 020142............. Cataflam (diclofenac Novartis
potassium) Tablets, 25 Pharmaceuticals Corp.
mg and 50 mg.
NDA 020254............. Voltaren XR (diclofenac Do.
sodium) Extended-
Release Tablets, 100
mg.
NDA 020631............. Morphine Sulfate SpecGx LLC.
Injection, 1 mg/mL and
2 mg/mL.
NDA 020768............. Zomig (zolmitriptan) iPR Pharmaceuticals,
Tablets, 2.5 mg and 5 Inc., c/o AstraZeneca
mg. Pharmaceuticals LP,
1800 Concord Pike,
Wilmington, DE 19803.
NDA 020897............. Ditropan XL (oxybutynin Janssen
chloride) Extended- Pharmaceuticals, Inc.
Release Tablets, 5 mg,
10 mg, and 15 mg.
NDA 020945............. Norvir (ritonavir) AbbVie Inc., 1 N.
Capsules, 100 mg. Waukegan Rd., North
Chicago, IL 60064.
NDA 021226............. Kaletra (lopinavir/ Do.
ritonavir) Capsules,
133.3 mg/33.3 mg.
NDA 021231............. Zomig-ZMT iPR Pharmaceuticals,
(zolmitriptan) Orally Inc., c/o AstraZeneca
Disintegrating Pharmaceuticals LP.
Tablets, 2.5 mg and 5
mg.
NDA 021360............. Sustiva (efavirenz) Bristol-Myers Squibb
Tablets, 300 mg and Company, P.O. Box
600 mg. 4000, Princeton, NJ
08543-4000.
NDA 022484............. Onmel (itraconazole) Sebela Ireland
Tablets, 200 mg. Limited, c/o Sebela
Pharmaceuticals Inc.
NDA 050679............. Maxipime (cefepime HCl) Hospira Inc, 275 North
for Injection, EQ 500 Field Dr., Bldg. H1-
mg base/vial, EQ 1 3S, Lake Forest, IL
gram base/vial, and EQ 60045.
2 gram base/vial.
NDA 203696............. Lupaneta Pack AbbVie Endocrinology
(leuprolide acetate Inc., 1 N Waukegan
injection and Rd., North Chicago,
norethindrone acetate IL 60064.
Tablets), 3.75 mg/
vial;5 mg and 11.25 mg/
vial;5 mg.
NDA 206302............. Byvalson (nebivolol HCl/ AbbVie Inc.
valsartan) Tablets, EQ
5 mg base/80 mg.
NDA 208042............. Cassipa (buprenorphine Teva Pharmaceuticals
HCl/naloxone HCl) USA, Inc., 577
Sublingual Film, EQ 16 Chipeta Way, Salt
mg base/EQ 4 mg base. Lake City, UT 84108.
NDA 208437............. Lonhala Magnair Kit Sumitomo Pharma
(glycopyrrolate) America, Inc., 84
Inhalation Solution, Waterford Dr.,
25 microgram/mL. Marlborough, MA
01752.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of May
23, 2024. Approval of each entire application is withdrawn, including
any strengths and dosage forms included in the application but
inadvertently missing from the table. Introduction or delivery for
introduction into interstate commerce of products listed in the table
without an approved NDA violates sections 505(a) and 301(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).
Drug products that are listed in the table that are in inventory on May
23, 2024, 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: April 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08657 Filed 4-22-24; 8:45 am]
BILLING CODE 4164-01-P