Recent Animal Drug Approvals
Drug Approval Information
Approved Animal Drug Products (Green Book Online)
Animal Drugs@FDA
Freedom of Information (FOI) Summaries for Approved Animal Drugs (FOI Summary)
Environmental Assessments/Findings of No Significant Impact (EA/FONSI)
NSAID Labels
Medicated Feed (Blue Bird) Labels
| Date | Application Number | Sponsor | Product Name | Species | Indications for Use/Effect of the Supplement | Public Documents |
|---|---|---|---|---|---|---|
| April 20, 2023 | NADA 141-570 | Boehringer Ingelheim Animal Health USA, Inc. | NexGard COMBO (esafoxolaner, eprinomectin, and praziquantel) | Cats | For the prevention of heartworm disease caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the treatment and control of Ixodes scapularis (black-legged tick) and Amblyomma americanum (lone star tick) infestations, and the treatment and control of roundworms (fourth stage larval and adult Toxocara cati), hookworms (fourth stage larval and adult Ancylostoma tubaeforme; adult Ancylostoma braziliense), and tapeworms (Dipylidium caninum) in cats and kittens 8 weeks of age and older, and weighing 1.8 lbs or greater. | FOI Summary |
| April 10, 2023 | NADA 038-439 | Phibro Animal Health Corp. | Terramycin 200 for Fish (oxytetracycline) | Catfish and freshwater-reared salmonids | This supplement provides for the addition of an indication for the control of mortality due to columnaris disease associated with Flavobacterium columnare in catfish and freshwater-reared salmonids. | FOI Summary |
| April 5, 2023 | ANADA 200-612 | Bimeda Animal Health Ltd. | Bimasone (flumethasone) | Horses, dogs and cats | Bimasone is recommended for the various rheumatic, allergic, dermatologic and other disease states which are known to be responsive to the anti-inflammatory corticoids. | FOI Summary |
| March 31, 2023 | ANADA 200-747 | ZyVet Animal Health Inc. | Maropitant Citrate (maropitant citrate) | Dogs | For the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs. | FOI Summary |
| March 30, 2023 | ANADA 200-746 | Norbrook Laboratories Ltd. | Tauramox (moxidectin) | Beef and nonlactating dairy cattle | For the treatment and control of internal and external parasites of cattle. | FOI Summary |
| March 29, 2023 | ANADA 200-744 | Provetica LLC | Modulis for Cats (cyclosporine) | Cats | For the control of feline allergic dermatitis as manifested by excoriations (including facial and neck), miliary dermatitis, eosinophilic plaques, and self-induced alopecia in cats at least 6 months of age and at least 3 lbs (1.4 kg) in body weight. | FOI Summary |
| March 21, 2023 | ANADA 200-745 | Parnell Technologies Pty. Ltd. | RESPIRmycin 25 (tulathromycin) | Swine, suckling calves, dairy calves, and veal calves | Swine: For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed. Suckling Calves, Dairy Calves, and Veal Calves: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. |
FOI Summary |
| March 21, 2023 | ANADA 200-743 | Provetica LLC | Modulis for Dogs (cyclosporine) | Dogs | For the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. | FOI Summary |
| February 24, 2023 | ANADA 200-741 | Aurora Pharmaceutical, Inc. | EpriGard | Beef and dairy cattle, including lactating dairy cattle | For the treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), lungworms, grubs, sucking and biting lice, chorioptic and sarcoptic mange mites, and horn flies. |
FOI Summary |
| February 9, 2023 | ANADA 200-701 | Chanelle Pharmaceuticals Manufacturing Ltd. | PARASEDGE Multi for Cats | Ferrets | This supplement provides for the addition of the following indications for ferrets: For the prevention of heartworm disease in ferrets caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations on ferrets. | FOI Summary |
| February 2, 2023 | ANADA 200-739 | ZYVET AH, Inc. | Carprofen | Dogs | For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs. |
FOI Summary |
| February 2, 2023 | ANADA 200-737 | ZYVET AH, Inc. | Enrofloxacin | Dogs and cats | For the management of diseases associated with bacteria susceptible to enrofloxacin. | FOI Summary |
| January 13, 2023 | ANADA 200-736 | ZYVET AH, Inc. | Marbofloxacin | Dogs and cats | For the treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin. | FOI Summary |
| January 13, 2023 | ANADA 200-735 | ZYVET AH, Inc. | Dexmedetomidine Hydrochloride | Dogs and cats | For use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia in dogs and cats. | FOI Summary |
| January 12, 2023 | ANADA 200-734 | Felix Pharmaceuticals Pvt. Ltd. | Praziquantel Tablets | Dogs | For the removal of the following canine cestodes: Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus and for the removal and control of Echinococcus multilocularis. |
FOI Summary |
| January 12, 2023 | ANADA 200-733 | Felix Pharmaceuticals Pvt. Ltd. | Marbofloxacin Chewable Tablets | Dogs and cats | For the treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin. | FOI Summary |
| January 12, 2023 | ANADA 200-721 | Norbrook Laboratories Ltd. | Midamox for Cats | Ferrets | This supplement provides for the addition of the following indications for ferrets: For the prevention of heartworm disease in ferrets caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations on ferrets. | FOI Summary |
| January 12, 2023 | NADA 141-426 | Intervet, Inc. | BRAVECTO | Dogs | This supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (Asian longhorned tick) infestations for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater. | FOI Summary |
| January 11, 2023 | ANADA 200-738 | Aurora Pharmaceutical, Inc. | DectoGard | Cattle | For the treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and sucking lice, horn flies, and mange mites in cattle. | FOI Summary |
| January 11, 2023 | ANADA 200-611 | Akorn Operating Company LLC | DetomiSed | Horses | For use as a sedative and analgesic to facilitate minor surgical and diagnostic procedures in mature horses and yearlings. |
FOI Summary |
| January 5, 2023 | ANADA 200-732 | Felix Pharmaceuticals Pvt. Ltd. | Carprofen Tablets | Dogs | For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs. | FOI Summary |
| December 23, 2022 | NADA 141-450 | Intervet, Inc. | Banamine Transdermal | Cattle/Beef cattle 2 months of age and older and dairy cattle. Not for use in beef and dairy bulls intended for breeding over 1 year of age, replacement dairy heifers over 20 months of age, dry dairy cows, dairy calves, or veal calves | This supplement provides for 1) the addition of a therapeutic indication “for the control of pyrexia associated with acute bovine mastitis”; 2) the addition of the lactating dairy cow target animal subclass for all approved indications; and 3) a milk discard time. | |
| December 20, 2022 | NADA 141-559 | Anzac Animal Health, LLC | Zycosan | Horses | For the control of clinical signs associated with osteoarthritis in horses | FOI Summary |
| December 15, 2022 | ANADA 200-455 | Bimeda Animal Health Ltd. | BiloVet | Broiler Chickens | This supplement provides for the addition of the indications and dosage and administration for the control of mortality caused by necrotic enteritis (NE) associated with Clostridium perfringens in broiler chickens. | FOI Summary |
| December 8, 2022 | NADA 141-566 | INCREVET INC | Bexacat | Cats | To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin | FOI Summary |
| December 2, 2022 | NADA 141-529 | Pharmgate Inc. | Pennitracin MD and Maxiban | Broiler Chickens | This supplement provides for the new indication, for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens, and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima in broiler chickens. | FOI Summary |
| December 2, 2022 | ANADA 200-377 | Bimeda Animal Health Ltd. | LinxMed-SP | Honey bees | This supplement provides for labeling changes to include the addition of a new indication for the control of American foulbrood (Paenibacillus larvae) in honey bees. | FOI Summary |
| November 14, 2022 | NADA 141-567 | Ishihara Sangyo Kaisha, Ltd. | PANOQUELL-CA1 | Dogs | Conditionally approved for the management of clinical signs associated with acute onset of pancreatitis in dogs. | FOI Summary |
| November 4, 2022 | ANADA 200-730 | Parnell Technologies Pty. Ltd. | RESPIRmycin | Beef cattle, non-lactating dairy cattle, suckling calves, dairy calves, veal calves, and swine | Beef and Non-Lactating Dairy Cattle BRD – For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. IBK – For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis. Foot Rot – For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii. Suckling Calves, Dairy Calves, and Veal Calves BRD – For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis. Swine – For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed. |
FOI Summary |