FDA Helps Improve U.S. Availability of FSH, an Important Drug for Embryo Transfer in Heifers and Cows

January 31, 2024

In response to a shortage of FDA-approved Folltropin (follicle stimulating hormone [FSH]), the U.S. Food and Drug Administration does not intend to object to the temporary importation of Pluset (porcine pituitary-derived follicle stimulating hormone and luteinizing hormone), by Alberta Veterinary Laboratories Ltd./Solvet (AVL/Solvet). Pluset is authorized for marketing in Spain and importation will improve availability of FSH product for use in cattle in the United States. FSH is an injectable prescription drug used to induce superovulation in reproductively mature heifers and cows, which is an important part of the embryo transfer process. 

Folltropin and Pluset are used for the same purpose, however, the composition and concentration of the active ingredients are different, as are the doses and dosage regimens. When imported Pluset is distributed in the U.S., it will be accompanied by a client information sheet for veterinarians and cattle producers with detailed information explaining how to use Pluset.

Although the imported Pluset product has not been evaluated or approved by the FDA, it is approved in Spain, the country of origin, and several other countries, and is subject to those countries’ regulatory standards, including adherence to good manufacturing practices.

The FDA will reassess the need for continued importation of Pluset as the availability of the FDA-approved product changes. More broadly, the FDA is monitoring supply chains and shortage risks to inform new strategies, authorities, and incentives, like those detailed in the FDA’s Animal and Veterinary Innovation Agenda (AVIA). Through such initiatives, the FDA aims to support strong pipelines and supply chains for FDA-regulated animal and veterinary products. 

100ml PP vaccine vial

250ml PE plastic vaccine bottle

Source from FDA: https://www.fda.gov/animal-veterinary/cvm-updates/fda-helps-improve-us-availability-fsh-important-drug-embryo-transfer-heifers-and-cows