FDA helping to alleviate U.S. shortage of FSH

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.

FDA said it 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).