Oxytetracycline medicated feed proposed marking claim expansion history...

Although the current (August 2008) product label for oxytetracycline (OTC) medicated feed (Terramycin® 200 for Fish from Phibro Animal Health; NADA #038-439) includes use for skeletal tissue marking in Pacific salmon, there still may be product on the market being sold with the old label, which does not have the skeletal marking claim. The history behind the old label not having a skeletal marking claim are rather complicated. In essence, when Phibro Animal Health (PAH) acquired the OTC medicated feed approval (from Pfizer Animal Health), the skeletal marking claim not on the existing Pfizer label, which PAH used as a basis for their label. In fact, PAH was unaware of the marking claim, but was made aware of it by AADAP during communication over new disease claims. Hence, it was not until PAH submitted data for new disease claims, and CVM accepted these new claims (9 July 2008), that the Pacific salmonid marking claim was proposed (and also accepted) to be included on the label.

To potentially complicate the history of this further, AADAP has proposed to CVM that the skeletal marking claim be expanded from Pacific salmon only to all salmonids. AADAP presently sponsors an INAD for OTC medicated feed for skeletal marking, and has done so for the last 8 years. As a requisite to maintaining the INAD, AADAP must annually report to CVM on the activities under the INAD, and CVM routinely responds to our annual report submission. In CVM's 2006 response letter it was suggested that the INAD information collected over the past years may be adequate to substantiate an expansion of the current marking claim. Following later discussions with CVM and the sponsor, AADAP began the process which ultimately lead to the formal submission (on 26 June 2007) to CVM, which claimed that OTC medicated feed effectively marks skeletal tissue of not only Pacific salmon, but all salmonids.

The following series of links, organized in chronological order, document the correspondence and associated data pertaining to AADAP's proposed expansion of the OTC medicated feed skeletal marking claim. The final link (21 December 2007) is CVM's response to our proposal. In essence, we were informed that our proposal (with minor modifications) and accompanying data will be acceptable for the label expansion provided we complete one pivotal effectiveness study on one salmonid species. AADAP has begun the preparatory work for that study and should be completed by spring of 2009.

CVM's response to AADAP 2005 OTC annual report (27 December 2006) and their suggestion to possibly pursue a skeletal marking label expansion.

AADAP's proposed label expansion submission letter (26 June 2007)

Table 1 - Summary of INAD #9332 data (26 June 2007)

Table 2 - Treatment-specific data for INAD #9332 OTC medicated feed trials conducted from 1999 through 2006 (26 June 2007)

AADAP's first letter clarifying the 26 June proposal submission (3 October 2007)

AADAP's second letter clarifying the 26 June proposal submission (8 November 2007)

CVM's response to AADAP's label expansion proposal (21 December 2007)





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LAST UPDATED: 16-Jan-2013