2024-08657. 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.

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of May 23, 2024.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, [e-mail].

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 § 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 § 314.150(c) is without prejudice to refiling.

Application No.	Drug	Applicant
NDA 007959	Tensilon (edrophonium chloride) Injection, 10 milligrams (mg)/milliliter (mL) Tensilon Preservative Free (edrophonium chloride) Injection, 10 mg/mL	PAI Holdings, LLC dba Pharmaceutical Associates, Inc., 1700 Perimeter Rd., Greenville, SC 29605.
NDA 009900	Cortef (hydrocortisone cypionate) Oral Suspension, Equivalent to (EQ) 10 mg base/5 mL	Pharmacia and Upjohn Co., 66 Hudson Blvd. East, New York, NY 10001.
NDA 015923	Haldol (haloperidol lactate) Injection, EQ 5 mg base/mL	Janssen Pharmaceuticals, Inc., 1000 U.S. Route 202, Raritan, NJ 08869.
NDA 017090	Tofranil-PM (imipramine pamoate) Capsules, EQ 75 mg hydrochloride (HCl), EQ 100 mg HCl, EQ 125 mg HCl, and EQ 150 mg HCl	SpecGx LLC, 385 Marshall Ave., Webster Groves, MO 63119.
NDA 018309	Topicort LP (desoximetasone) Emollient Cream, 0.05%	Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532.
NDA 018401	Buprenex (buprenorphine HCl) Injection, EQ 0.3 mg base/mL	Indivior Inc., 10710 Midlothian Turnpike, Suite 125, North Chesterfield, VA 23235.
NDA 019201	Voltaren (diclofenac sodium) Delayed-Release Tablets, 25 mg, 50 mg, and 75 mg	Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936.
NDA 019425	Trandate (labetalol HCl) Injection, 5 mg/mL	Sebela Ireland Limited, c/o Sebela Pharmaceuticals Inc., 645 Hembree Pkwy., Suite 1, Roswell, GA 30076.
NDA 020142	Cataflam (diclofenac potassium) Tablets, 25 mg and 50 mg	Novartis Pharmaceuticals Corp.
NDA 020254	Voltaren XR (diclofenac sodium) Extended-Release Tablets, 100 mg	Do.
NDA 020631	Morphine Sulfate Injection, 1 mg/mL and 2 mg/mL	SpecGx LLC.
NDA 020768	Zomig (zolmitriptan) Tablets, 2.5 mg and 5 mg	iPR Pharmaceuticals, Inc., c/o AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19803.
NDA 020897	Ditropan XL (oxybutynin chloride) Extended-Release Tablets, 5 mg, 10 mg, and 15 mg	Janssen Pharmaceuticals, Inc.
NDA 020945	Norvir (ritonavir) Capsules, 100 mg	AbbVie Inc., 1 N. Waukegan Rd., North Chicago, IL 60064.
NDA 021226	Kaletra (lopinavir/ritonavir) Capsules, 133.3 mg/33.3 mg	Do.
NDA 021231	Zomig-ZMT (zolmitriptan) Orally Disintegrating Tablets, 2.5 mg and 5 mg	iPR Pharmaceuticals, Inc., c/o AstraZeneca Pharmaceuticals LP.
NDA 021360	Sustiva (efavirenz) Tablets, 300 mg and 600 mg	Bristol-Myers Squibb Company, P.O. Box 4000, Princeton, NJ 08543-4000.
NDA 022484	Onmel (itraconazole) Tablets, 200 mg	Sebela Ireland Limited, c/o Sebela Pharmaceuticals Inc.
NDA 050679	Maxipime (cefepime HCl) for Injection, EQ 500 mg base/vial, EQ 1 gram base/vial, and EQ 2 gram base/vial	Hospira Inc, 275 North Field Dr., Bldg. H1-3S, Lake Forest, IL 60045.
NDA 203696	Lupaneta Pack (leuprolide acetate injection and norethindrone acetate Tablets), 3.75 mg/vial;5 mg and 11.25 mg/vial;5 mg	AbbVie Endocrinology Inc., 1 N Waukegan Rd., North Chicago, IL 60064.
NDA 206302	Byvalson (nebivolol HCl/valsartan) Tablets, EQ 5 mg base/80 mg	AbbVie Inc.
NDA 208042	Cassipa (buprenorphine HCl/naloxone HCl) Sublingual Film, EQ 16 mg base/EQ 4 mg base	Teva Pharmaceuticals USA, Inc., 577 Chipeta Way, Salt Lake City, UT 84108.
NDA 208437	Lonhala Magnair Kit (glycopyrrolate) Inhalation Solution, 25 microgram/mL	Sumitomo Pharma America, Inc., 84 Waterford Dr., Marlborough, MA 01752.

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.