FDA announces limited return of heartworm drug for dogs
FDA announced a limited return of a reformulated heartworm prevention drug for dogs, which had been withdrawn because of serious, life-threatening adverse reactions, including loss of appetite, lethargy; vomiting, seizures, difficulty walking, jaundice; and bleeding disorders, allergies, convulsions, followed in some cases by death.
The FDA is amending the animal drug regulations to reflect approval of a new animal drug application filed by Intervet, Inc. The NADA provides for the veterinary prescription use of a suspension containing orbifloxacin, mometasone furoate monohydrate, and posaconazole for the treatment of otitis externa in dogs.