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Approval for
PARASITE-S (formalin) July 8, 1998 The following is important information regarding FDA’s recent approval of a supplemental new animal drug application for PARASITE-S (formalin) sponsored by Western Chemical, Inc. On June 18, 1998 Western Chemical, Inc. received written notice from FDA/CVM that several supplemental applications for their currently approved PARASITE-S have been approved. This supplemental application was approved as of the date of the letter. This product has been approved by FDA for use in the control of certain external protozoan parasites on trout, salmon, catfish, largemouth bass, bluegills and shrimp, and as a fungicide for trout, salmon and esocid eggs. The approved supplements include use of PARASITE-S as a parasiticide for "ALL" finfish and as a fungicide on the eggs of "ALL" finfish. This approval by FDA is significant in that the approvals are not for specific species but for all finfish. The other uses previously approved, for example on shrimp which is not a finfish, remain in effect also. Western Chemical, Inc. was kind enough to share this information prior to the publication of a notice of this approval in the Federal Register which is anticipated within several weeks. It is important to note that PARASITE-S is currently the ONLY formalin product approved by FDA for expanded use on all finfish. Other formalin products are approved by FDA but their uses are still restricted by the species identified on the product labels. The information contained within the Federal Register final rule will also be distributed to you when this notice is published. For more information about this product contact:
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