APVMA reaches the conclusion of the review of virginiamycin

see also Gazette 4 5 April 2005 page 27

As an outcome of the 1999 report of the Joint Expert Advisory Committee on Antibiotic Resistance (JETACAR), the APVMA has reconsidered the registration and label approvals of products containing the antibiotic virginiamycin. The reconsideration (review) commenced in 2000 and a Draft Review Report was released for public consultation in April 2003. In November 2004 the APVMA published its findings of the reconsideration (review).

On 28 February 2005, the APVMA formally made the regulatory decision that it is not satisfied that the use of virginiamycin as a growth promotant, or for long-term prophylaxis, would not be likely to have an effect that is harmful to human health. The APVMA cancelled the registrations and label approvals of three products listed in Table 1 that have growth promotion uses.

The APVMA decided to continue the registration of other products containing virginiamycin used to prevent necrotic enteritis in broiler chickens and to treat and prevent lactic acidosis in cattle and sheep, but with revised label instructions that limit re-treatment and duration of use of the antibiotic. Table 2 contains superseded label approvals for three products with these use patterns. The APVMA has cancelled these superseded labels.

The APVMA has issued permits under section 114 of the AgVet Codes to enable sell-out and use of the cancelled products and products with cancelled labels. The permits outline the permitted dealings of the relevant products. The permits may be viewed.

CANCELLED PRODUCT REGISTRATIONS AND LABEL APPROVALS

APVMA reaches the conclusion of the review of virginiamycin

Product number	Name of product	Registrant	Label approval numbers	Relevant permit number
38329	Stafac 20 Feed Premix	Phibro Animal Health Pty Ltd	38329/01 38329/0698	PER8299
41286	Virginiamycin 20	Agribusiness Products Pty Ltd	41286/0698 41286/1/0404	PER8300
41476	Virginiamycin 20	Lienert Australia Pty Ltd	41476/0198	PER8301

CANCELLED LABEL APPROVALS

Table 2: Cancelled label approvals

Product number	Name of product	Registrant	Label approval numbers	Relevant permit number
51354	Eskalin 500 Feed Premix	Phibro Animal Health Pty Ltd	51354/1198 51354/0302	PER8299
49111	Eskalin Wettable Powder Spray-on Feed Premix	Phibro Animal Health Pty Ltd	49111/0997	PER8299
46049	Eskalin Feed Premix for Cattle	Phibro Animal Health Pty Ltd	46049/01 46049/0102	PER8299

VARIED LABELS

The APVMA has decided to vary the labels of products in Table 3, by including restraints on the length of time the products may be used and limiting treatment to once in a twelve-month period. The APVMA has not implemented this decision pending the outcome of legal action taken by the registrant.

Table 3: Label approvals proposed to be varied

Product number	Name of product	Registrant	Label approval numbers
51354	Eskalin 500 Feed Premix	Phibro Animal Health Pty Ltd	51354/0103
49111	Eskalin Wettable Powder Spray-On Feed Premix	Phibro Animal Health Pty Ltd	49111/50/0904 49111/50C/0904
46049	Eskalin Feed Premix for Cattle	Phibro Animal Health Pty Ltd	46049/25/0104

For further information about this matter please contact:

Linden Moffatt
Veterinary Medicines Program
Australian Pesticides & Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

phone: (02) 6272 4980
fax: (02) 6272 3218
email: linden.moffatt@apvma.gov.au