Source: https://www.federalregister.gov/documents/2011/03/31/2011-7560/animal-drugs-feeds-and-related-products-withdrawal-of-approval-of-new-animal-drug-applications
Timestamp: 2017-08-21 20:53:03
Document Index: 719863181

Matched Legal Cases: ['§\u2009510', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009522', '§\u2009524', '§\u2009524', '§\u2009558', '§\u2009558', '§\u2009558']

Federal Register :: Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Cuprimyxin; Diethylcarbamazine; Levamisole; Nitrofurazone; Phenylbutazone; Pyrantel; Tylosin; Tylosin and Sulfamethazine
A Rule by the Food and Drug Administration on 03/31/2011
This rule is effective April 11, 2011.
76 FR 17776
Docket No. FDA-2011-N-0160
2011-7560
https://www.federalregister.gov/d/2011-7560 https://www.federalregister.gov/d/2011-7560
The sponsors of the 13 approved NADAs listed in table 1 have requested that FDA withdraw approval because the products are no longer manufactured or marketed.
Table 1—Voluntary Requests for Withdrawal of Approval of 13 NADAs
21 CFR section affected (sponsor's drug labeler code)
Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 07054-1298 NADA 093-029, UNITOP Cream (cuprimyxin) 524.520 (063238).
Quali-Tech Products, Inc., 318 Lake Hazeltine Dr., Chaska, MN 55318 NADA 097-981, TYLAN 40 Sulfa-G Premix (tylosin phosphate/sulfamethazine) 558.630 (016968).
Abraxis Pharmaceutical Products, Division of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, IL 60018 NADA 100-840, Chorionic Gonadotropin for Injection (chorionic gonadotropin) 522.1081 (063323).
Furst-McNess Co., Freeport, IL 61032 NADA 100-991, McNess Custom Premix L200 (tylosin phosphate) 558.625 (010439).
Fort Dodge Animal Health, Division of Wyeth Holdings, a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 NADA 101-079 TRAMISOL-10% Pig Wormer (levamisole) Not codified (000856).
Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704 NADA 101-905, Mill Co-Medicator TY-10 (tylosin phosphate) 558.625 (017139).
Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704 NADA 101-906, Mill Co-Medicator TS-40 Premix (tylosin phosphate/sulfamethazine) 558.630 (017139).
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514 NADA 102-824,Phenylbutazone Tablets (phenylbutazone) 520.1720a (055246).
Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN 56011 NADA 108-487, DEC Tabs (diethylcarbamazine citrate) 520.622a (015579).
Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN 56011 NADA 108-863, DEC Chewable Tabs (diethylcarbamazine citrate) 520.622c (015579).
Furst-McNess Co., Freeport, IL 61032 NADA 140-820, TYLAN 40 Sulfa-G Premix (tylosin phosphate/sulfamethazine) 558.630 (010439).
Furst-McNess Co., Freeport, IL 61032 NADA 140-825, BANMINTH Intermediate Premix (pyrantel tartrate) 558.485 (010439).
Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 40511 NADA 140-910, NFZ Wound Powder (nitrofurazone) 524.1580c (050749).
In a notice published elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 93-029, 97-981, 100-840, 100-991, 101-079, 101-905, 101-906, 102-824, 108-487, 108-863, 140-820, 140-825, and 140-910, and all supplements and amendments thereto, is withdrawn, effective April 11, 2011. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these withdrawals of approval and a current format.
Following these changes of sponsorship, Abraxis Pharmaceutical Products, Furst-McNess Co., Roche Vitamins, Inc., Waterloo Mills Co., and Wendt Laboratories, Inc., are no longer the sponsors of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for these firms.
2. In § 510.600, in the table in paragraph (c)(1), remove the entries for “Abraxis Pharmaceutical Products”, “Furst-McNess Co.”, “Roche Vitamins, Inc.”, “Waterloo Mills Co.”, and “Wendt Laboratories, Inc.”; and in the table in paragraph (c)(2), remove the entries for “010439”, “015579”, “017139”, “063238”, and “063323”.
4. In § 520.622a, remove and reserve paragraph (a)(1); in paragraph (a)(5), remove “000081' and in its place add “No. 000061”; and revise paragraph (b)(2) to read as follows:
Diethylcarbamazine citrate tablets.
5. In § 520.622c, remove and reserve paragraph (b)(1); remove reserved paragraph (b)(7); and revise paragraph (c)(3) to read as follows:
Diethylcarbamazine citrate chewable tablets.
6. In § 520.1720a, remove and reserve paragraph (b)(4).
End Amendment Part Start Part Start Printed Page 17778
8. In paragraph (b)(2) of § 522.1081, remove “Nos. 058639 and 063323” and in its place add “No. 058639”.
10. Remove § 524.520.
11. In paragraph (b) of § 524.1580c, remove “Nos. 000010, 000069, and 050749” and in its place add “Nos. 000010 and 000069”.
13. In § 558.485, in paragraph (b)(3), remove “010439”.
14. In § 558.625, remove and reserve paragraphs (b)(42) and (b)(45).
15. In § 558.630, remove and reserve paragraph (b)(4); and in paragraph (b)(5), remove “010439,” and “016968,”.
[FR Doc. 2011-7560 Filed 3-30-11; 8:45 am]