Liebel-Flarsheim Company LLC, et al.; Withdrawal of Approval of 11 New Drug Applications
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 writi...
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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES:
Approval is withdrawn as of August 2, 2019.
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.
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 016983
Conray 30 (iothalamate meglumine) Injection, 30%
Liebel-Flarsheim Co. LLC, 1034 South Brentwood Blvd., Suite 800, Richmond Heights, MO 63117.
NDA 018972
Cordarone (amiodarone HCl) Tablets, 200 mg
Wyeth Pharmaceuticals LLC, P.O. Box 8299, Philadelphia, PA 19101-8299.
Javelin Pharmaceuticals, Inc., a subsidiary of Hospira Inc., 275 North Field Dr., Dept. 0392, Bldg. H1-3S, Lake Forest, IL 60045.
NDA 203568
Kynamro (mipomersen sodium) Injection, 200 mg/mL
Kastle 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Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of August 2, 2019. Approval of each entire application is withdrawn, including any strengths or products inadvertently missing from the table.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.
Use this for formal legal and research references to the published document.
84 FR 31872
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Liebel-Flarsheim Company LLC, et al.; Withdrawal of Approval of 11 New Drug Applications,” thefederalregister.org (July 3, 2019), https://thefederalregister.org/documents/2019-14219/liebel-flarsheim-company-llc-et-al-withdrawal-of-approval-of-11-new-drug-applications.
21 CFR 314.150(c)
21 U.S.C. 331(a)