83 FR 63 pgs. 14016-14017 - Mallinckrodt Inc. et al.; Withdrawal of Approval of Five New Drug Applications
Type: NOTICEVolume: 83Number: 63Pages: 14016 - 14017
Pages: 14016, 14017Docket number: [Docket No. FDA-2018-N-1141]
FR document: [FR Doc. 2018-06579 Filed 3-30-18; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
[top]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1141]
Mallinckrodt Inc. et al.; Withdrawal of Approval of Five New Drug Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is withdrawing approval of five new drug applications (NDAs) from multiple applicants. The holders of the applications 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of May 2, 2018.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.
SUPPLEMENTARY INFORMATION:
The holders of the applications 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.
[top]
| Application No. | Drug | Applicant |
|---|---|---|
| NDA 006383 | Methadone Hydrochloride (HCl) Powder, 50 grams (g)/bottle, 100 g/bottle, and 500 g/bottle | Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO 63042. |
| NDA 020716 | Vicoprofen (hydrocodone bitartrate and ibuprofen) Tablets, 7.5 milligrams (mg)/200 mg | AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL 60064. |
| NDA 021692 | Ultram ER (tramadol HCl) Extended-Release Tablets, 100 mg, 200 mg, and 300 mg | Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. |
| NDA 207621 | Troxyca ER (oxycodone HCl and naltrexone HCl) Extended-Release Capsules, 10 mg/1.2 mg, 20 mg/2.4 mg, 30 mg/3.6 mg, 40 mg/4.8 mg, 60 mg/7.2 mg, and 80 mg/9.6 mg | Pfizer Inc., 235 East 42nd St., New York, NY 10017. |
| NDA 207975 | Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg | Teva Branded Pharmaceutical Products R&D, Inc., 41 Moores Rd., P.O. Box 4011, Frazer, PA 19355. |
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of May 2, 2018. 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 May 2, 2018 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: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06579 Filed 3-30-18; 8:45 am]
BILLING CODE 4164-01-P