AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is withdrawing approval of six 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES:
Approval is withdrawn as of December 30, 2019.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-402-6980, Martha.Nguyen@fda.hhs.gov.
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 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. | Drug | Applicant |
|---|---|---|
| ANDA 040806 | Mepivacaine Hydrochloride (HCl) Injection USP, 3%, 30 milligrams (mg)/milliliter (mL) | Hospira, Inc., 275 North Field Dr., Bldg. H, Lake Forest, IL 60045. |
| ANDA 077523 | Fluconazole for Oral Suspension, 50 mg/5 mL and 200 mg/5 mL | IVAX Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. |
| ANDA 078772 | Epinephrine and Lidocaine HCl, 0.01 mg/mL; 2% and 0.02 mg/mL; 2% | Hospira, Inc. |
| ANDA 079138 | Articaine HCl and Epinephrine Bitartrate Injection, 4%; EQ 0.017 mg base/1.7 mL, 4%; EQ 0.01 mg base/mL | Do. |
| ANDA 204236 | Norethindrone Acetate Tablets, 5 mg | Aurobindo Pharma Ltd., 279 Princeton-Hightstown Rd., East Windsor, NJ 08520. |
| ANDA 204421 | Tramadol HCl Extended-Release Tablets, 100 mg, 200 mg, and 300 mg | Do. |
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of December 30, 2019. Approval of each entire application is withdrawn, including any strengths or products inadvertently missing from the table.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 December 30, 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.
Dated: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25901 Filed 11-27-19; 8:45 am]
BILLING CODE 4164-01-P