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Liebel-Flarsheim Company LLC, et al.; Withdrawal of Approval of 11 New Drug Applications

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA or Agency) is withdrawing approval of 11 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Approval is withdrawn as of August 2, 2019.

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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.

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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.DrugApplicant
NDA 016983Conray 30 (iothalamate meglumine) Injection, 30%Liebel-Flarsheim Co. LLC, 1034 South Brentwood Blvd., Suite 800, Richmond Heights, MO 63117.
NDA 018972Cordarone (amiodarone HCl) Tablets, 200 mgWyeth Pharmaceuticals LLC, P.O. Box 8299, Philadelphia, PA 19101-8299.
NDA 019009Maxair Inhaler (pirbuterol acetate inhalation aerosol), equivalent to (EQ) 0.2 mg base/inhalationBausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NH 08807.
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NDA 019292MD-76R (diatrizoate meglumine and diatrizoate sodium) Injection, 66%/10%Liebel-Flarsheim Co. LLC.
NDA 020014Maxair Autohaler (pirbuterol acetate inhalation aerosol), EQ 0.2 mg base/inhalationBausch Health US, LLC.
NDA 021041DepoCyt (cytarabine liposome) Injection, 10 mg/mLPacira Pharmaceuticals, Inc., 5 Sylvan Way, Suite 300, Parsippany, NJ 07054.
NDA 021338Ionsys (fentanyl iontophoresis transdermal system), 40 mcg/activationThe Medicines Co., 8 Sylvan Way, Parsippany, NJ 07054.
NDA 021575Fosamax (alendronate sodium) Oral Solution, EQ 70 mg base/75 mLMerck Sharp & Dohme Corp., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889-0100.
NDA 022222Ultresa (pancrelipase (amylase, lipase, protease)), Delayed-Release Capsules, 8,000 USP Units/4,000 USP Units/8,000 USP Units and 27,600 USP Units/13,800 USP Units/27,600 USP Units, and 41,400 USP Units/20,700 USP Units/41,400 USP Units, and 46,000 USP Units/23,000 USP Units/46,000 USP UnitsAllergan Sales, LLC, 5 Giralda Farms, Madison, NJ 07940.
NDA 022396Dyloject (diclofenac sodium) Injection, 37.5 mg/mLJavelin Pharmaceuticals, Inc., a subsidiary of Hospira Inc., 275 North Field Dr., Dept. 0392, Bldg. H1-3S, Lake Forest, IL 60045.
NDA 203568Kynamro (mipomersen sodium) Injection, 200 mg/mLKastle Therapeutics, 181 West Madison St., Suite 300, Chicago, IL 60602.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of August 2, 2019. Approval of each entire application is withdrawn, including any strengths or products 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 August 2, 2019 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.

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Dated: June 28, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2019-14219 Filed 7-2-19; 8:45 am]