The U.S. Food and Drug Administration has completed its review of the application and issued an approval for FOLLTROPIN, which is intended to induce superovulation—ovulation of multiple eggs in one heat cycle—for beef and dairy heifers and cows.
Concurrently, FDA has issued an Import Alert identifying three unapproved follicle stimulating hormone (FSH) drugs that may be detained without physical examination when offered for import because an FDA-approved FSH product is now available.
FDA has also issued letters to inform bovine veterinarians and beef and dairy professionals of these actions. The letters remind veterinarians and beef and dairy professionals of the benefits of FDA-approved drugs, which must be shown to be safe and effective in order to be approved. Unapproved animal drugs have not been reviewed by FDA and may not meet FDA’s strict standards for safety and effectiveness. Drug companies that make and sell these unapproved animal drugs also unfairly compete against drug companies that invest the time and financial resources to develop the necessary data for FDA review and approval.
FOLLTROPIN is currently the only marketed FDA-approved FSH drug for cattle in the U.S. FOLLTROPIN is manufactured by Bioniche Animal Health USA, Inc. Federal law restricts this drug to use by or on the order of a licensed veterinarian.