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Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Approval is withdrawn as of March 14, 2019.

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Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945,

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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 described 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
ANDA 065343Epirubicin Hydrochloride (HCl) Injection USP, 10 milligrams (mg)/5 milliliters (mL), 50 mg/25 mL, 150 mg/75 mL, and 200 mg/100 mLHospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045.
ANDA 070562Flurazepam HCl Capsules USP, 15 mgPharmaceutical Basics, Inc., 301 South Cherokee St., Denver, CO 80223.
ANDA 070563Flurazepam HCl Capsules USP, 30 mgDo.
ANDA 071808Flurazepam HCl Capsules USP, 15 mgHalsey Drug Co., Inc., 1827 Pacific St., Brooklyn, NY 11233.
ANDA 071809Flurazepam HCl Capsules USP, 30 mgDo.
ANDA 076827Vinorelbine Injection USP, Equivalent to 10 mg base/mLHospira, Inc.
ANDA 077736Polyethylene Glycol 3350 Powder for Oral Solution, 17 grams/scoopfulBreckenridge Pharmaceutical, Inc., 6111 Broken Sound Parkway NW, Suite 170, Boca Raton, FL 33487.
ANDA 085763Glutethimide Tablets, 500 mgChelsea Laboratories, Inc., 896 Orlando Ave., West Hampstead, NY 11552.
ANDA 085791Pentobarbital Sodium Capsules, 100 mgDo.
ANDA 087297Glutethimide Tablets, 500 mgPhoenix Pharmaceuticals, Inc., 111 Leuning St., South Hackensack, NJ 07606.
ANDA 088819Aristocort A (triamcinolone acetonide) Cream, 0.1%Astellas Pharma U.S., Inc., Three Parkway North, Deerfield, IL 60015.
ANDA 089459Glutethimide Tablets, 500 mgHalsey Drug Co., Inc.
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Therefore, approval of the applications listed in the table and all amendments and supplements thereto, are hereby withdrawn as of March 14, 2019. 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 14, 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: February 7, 2019.

Lowell J. Schiller,

Acting Associate Commissioner for Policy.

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[FR Doc. 2019-02032 Filed 2-11-19; 8:45 am]