The U.S. Food and Drug Administration’s Center for Veterinary Medicine announced today that it is taking steps to help increase the availability of novel treatments for rare diseases and conditions in dogs and cats, also known as “minor use” drugs.
To qualify for minor use status, a new animal drug must be intended to treat a disease or condition:
• in a major species (dogs, cats, horses, cattle, swine, chickens and turkeys);
• that occurs infrequently or in limited geographic areas;
• and in less than a “small number” of animals annually.
The FDA is increasing the threshold of “small numbers” that helps a medicine qualify as a minor use, meaning that more treatments for dogs and cats are likely to meet the criteria. For dogs, the new threshold is 80,000 cases annually (up from 70,000). For cats, the number increased from 120,000 to 150,000 cases annually. [read more]