Animal & Veterinary
First Ever Conditional Approval Under MUMS
FDA Veterinarian Newsletter 2007 Volume XXII, No I
The Food and Drug Administration has announced the first ever “conditional approval” of a product, as authorized under the Minor Use and Minor Species Animal Health Act (MUMS Act) of 2004, which allows the sponsor to begin marketing a product while continuing to collect substantial evidence of effectiveness.
The product is AQUAFLOR®-CA1 (florfenicol) Type A medicated article for the control of mortality in catfish due to columnaris disease associated with Flavobacterium columnare. Columnaris disease is a major bacterial disease of catfish in the United States, and is estimated to cause up to 25 percent of the disease losses in catfish annually.
As the product name indicates, the “CA” means that the drug is conditionally approved, and the number “1” means that this is the first conditionally approved application for this formulation. In addition, the product labeling includes a specific statement required by the MUMS Act, “Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-259.”
Conditional approval allows the sponsor to market a drug before collecting all necessary effectiveness data as long as the sponsor has demonstrated that there is a reasonable expectation that the drug is effective. The sponsor may continue marketing AQUAFLOR®-CA1 for up to 5 years, subject to annual renewals, while collecting substantial evidence of effectiveness.
The sponsor is Schering-Plough Animal Health Corporation, Summit, NJ. FDA announced the conditional approval in April.
FDA reviewed extensive data to ensure the product met all necessary -target animal safety, environmental safety, and human food safety standards. FDA concluded that catfish fed florfenicol are safe for human consumption when florfenicol is administered according to the label directions. FDA also concluded that the data submitted demonstrated that there is a reasonable expectation that AQUAFLOR®-CA1 is effective for columnaris disease in catfish.
AQUAFLOR®-CA1 is a veterinary feed directive drug, meaning that the medicated feed can be fed only on the order of a licensed veterinarian. The extralabel or off label use of medicated feed containing florfenicol is prohibited.
AQUAFLOR®-CA1 has been declared a designated new animal drug by FDA under provisions of the MUMS Act. This designation entitles AQUAFLOR®-CA1 to 7 years of exclusive marketing rights beginning on the date of conditional approval. The exclusive marketing rights associated with the designation status protect against generic copying and other pioneer products for the same drug with the same formulation and intended use.
If the drug does not have designation status, even if it is destined for use in a minor species or for a minor use, the regular exclusivity rules apply as for any New Animal Drug Application. The protection is only against generic copying. The sponsor should qualify for 5 years of exclusivity for an original (new entity) application and for 3 years for a supplemental application. The protection for the supplemental application relies on the sponsor having provided significant new data supporting target animal safety or effectiveness to gain the approval.