FDA helping to alleviate U.S. shortage of FSH

Source: Farm Progress. The original article is posted here.

FDA helping to alleviate U.S. shortage of FSH
In response to a shortage of FDA-approved Folltropin (follicle stimulating hormone [FSH]), the U.S. Food and Drug Administration announced Jan. 31 that it 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. Pluset is authorized for marketing in Spain and importation will improve availability of FSH product for U.S. cattle producers who utilize embryo transfer on their operations

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).

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