Source: https://www.federalregister.gov/documents/2008/03/10/E8-4603/implantation-or-injectable-dosage-form-new-animal-drugs-change-of-sponsor-ferric-oxide-injection
Timestamp: 2017-09-25 01:46:51
Document Index: 517414388

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

Federal Register :: Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Ferric Oxide Injection; Gleptoferron Injection; Iron Dextran Complex Injection; Iron Hydrogenated Dextran Injection
Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Ferric Oxide Injection; Gleptoferron Injection; Iron Dextran Complex Injection; Iron Hydrogenated Dextran Injection
A Rule by the Food and Drug Administration on 03/10/2008
This rule is effective March 10, 2008.
https://www.federalregister.gov/d/E8-4603 https://www.federalregister.gov/d/E8-4603
Start Printed Page 12635
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) for injectable iron supplements used in baby pigs from Boehringer Ingelheim Vetmedica, Inc., to Animal Health Pharmaceuticals, LLC. In addition, FDA is taking this opportunity to consolidate injectable iron supplements in a single section of the Code of Federal Regulations (CFR). This is being done to simplify and clarify the regulations.
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 106-772 for Iron-GARD Injection 100 milligrams/milliliter (mg/mL) and NADA 134-708 for Iron-GARD Injection 200 mg/mL to Animal Health Pharmaceuticals, LLC, 1805 Oak Ridge Circle, suite 101, St. Joseph, MO 64506. Accordingly, the regulations are amended in 21 CFR 522.1182 to reflect these changes of sponsorship.
In addition, FDA is taking this opportunity to consolidate such injectable iron supplements in a single section of the CFR. This is being done to simplify and clarify the regulations.
2. Remove § 522.940.
3. Remove § 522.1055.
4. Revise § 522.1182 to read as follows:
(a) Specifications. See § 510.440 of this chapter. Each milliliter (mL) of solution contains the equivalent of:
(b) Sponsors and conditions of us e. It is used in baby pigs by sponsors in § 510.600(c) of this chapter as follows:
(1) Nos. 059130 and 068718 for use of product described in paragraph (a)(1)(i) of this section as follows:
(2) No. 000856 for use of product described in paragraph (a)(1)(i) of this section as follows:
(3) Nos. 000061 and 062408 for use of product described in paragraph (a)(1)(i) of this section as follows:
(4) Nos. 051311 and 053501 for use of product described in paragraph (a)(1)(ii) of this section as follows:
(5) No. 053501 for use of product described in paragraph (a)(1)(iii) of this section as follows:
(6) Nos. 058005 and 059130 for use of product described in paragraph (a)(1)(iii) of this section as follows:
(7) Nos. 059130 and 068718 for use of product described in paragraph (a)(2) of this section as follows:
(8) No. 062408 for use of product described in paragraph (a)(2) of this section as follows:
5. Remove § 522.1183.
[FR Doc. E8-4603 Filed 3-7-08; 8:45 am]