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[切片] FDA Green Book Recent Animal Drug Approvals - 宠物用药段 (Dogs/Cats) 2024-11 至 2026-06 (55 条)

fda_green_book_recent_approvals_pet_drug_2024_2026

us-2026 2657 tok en 2026-07-20

Excerpted from the pet-drug segment of the FDA Green Book Recent Animal Drug Approvals page (with NADA / ANADA application numbers) (Dogs / Cats / Dogs and cats / Horses and Dogs, etc.), covering the period 2024-11-06 to 2026-06-29.

  • Source page URL: https://www.fda.gov/animal-veterinary/approved-animal-drug-products-green-book/recent-animal-drug-approvals
  • Content timestamp (page header): 02/05/2025
  • Pull date: 2026-07-20
  • Total rows in the source table: 93 (excluding header); pet-related rows: 55
  • Species distribution: Dogs=38 / Cats=8 / Dogs and cats=6 / Horses and Dogs=2 / Dog=1

Key Entries (Reverse Chronological)

2026 H1 (Jan-Jun) — 22 entries

DateApplication No.CompanyProductSpeciesPrimary Use
Jun 29, 2026200-773Huvepharma EOOD(Note: CORID® amprolium oral solution 013-149 is a bovine product — coccidiosis in calves — and is NOT a pet drug; excluded from this pet-drug slice)
June 22, 2026200-856ZyVet Animal Health, Inc.Meloxicam Oral SuspensionDogsOsteoarthritis pain control
Jun 12, 2026141-459Intervet, Inc.BRAVECTO® (fluralaner topical solution)CatsKills Gulf Coast ticks for 12 weeks; kittens ≥12 weeks, ≥2.6 lbs
Jun 8, 2026200-858Felix Pharmaceuticals Pvt. Ltd.Nitenpyram TabletsDogs and catsFleas
May 12, 2026141-606TriviumVetLIAVIUM™-CA1 (pregabalin chewable tablets)DogsPain management for Chiari-like malformation and syringomyelia
May 6, 2026141-627Orion Corp.Tessie® (tasipimidine oral solution)DogsNoise aversion + separation anxiety
Apr 29, 2026141-613Ceva Sante AnimaleAMODIP® (amlodipine besylate tablets)CatsControl of systemic hypertension
Apr 20, 2026200-786Norbrook Laboratories Ltd.Loxicom® (meloxicam oral suspension)DogsOsteoarthritis
Apr 8, 2026200-848Cronus Pharma Specialities India Private Ltd.Florfinasone™ Otic (florfenicol, terbinafine, mometasone furoate)DogsOtitis externa (yeast + bacteria)
Mar 16, 2026141-599Intervet, Inc.BRAVECTO® QUANTUM (fluralaner injectable)DogsAsian longhorned tick + Gulf Coast tick, 12 months
Mar 16, 2026141-406Boehringer Ingelheim Animal Health USA, Inc.NexGard® (afoxolaner)DogsKills Gulf Coast ticks
Mar 9, 2026200-804Cronus PharmaRobenacoxib InjectionDogs and CatsPost-operative pain (soft tissue in dogs / orthopedic in cats)
Feb 25, 2026141-596Intervet, Inc.Numelvi™ (atinvicitinib tablets)DogsControl of pruritus associated with allergic dermatitis (≥6 months of age)
Feb 23, 2026200-822Baxter Healthcare CorporationANIRANE (isoflurane)Horses and DogsInduction and maintenance of anesthesia
Feb 6, 2026200-838Felix Pharmaceuticals Pvt. Ltd.Atipamezole Hydrochloride InjectionDogsReversal of sedation
Jan 15, 2026141-575Boehringer Ingelheim Animal Health USA, Inc.Vetmedin® Solution (pimobendan oral solution)DogsDelays onset of congestive heart failure in Stage B2 preclinical myxomatous mitral valve disease (MMVD)
Jan 13, 2026141-518Intervet, Inc.BRAVECTO® PLUS (fluralaner + moxidectin)CatsKills Gulf Coast ticks for 2 months
Jan 12, 2026200-833Felix Pharmaceuticals Pvt. Ltd.Maropitant Citrate TabletsDogsAcute vomiting + prevention of motion-sickness vomiting
Jan 9, 2026141-615Pegasus Laboratories, Inc.KBROVET® (potassium bromide chewable tablets)DogsControl of idiopathic epilepsy

2025 H2 (Jul-Dec) — 12 selected entries

  • Dec 22, 2025 | 200-834 | Felix Pharmaceuticals Pvt. Ltd. | Praziquantel Tablets | Cats | Feline tapeworms (Dipylidium caninum + Taenia taeniaeformis)
  • Dec 22, 2025 | 200-832 | ZyVet Animal Health, Inc. | Robenacoxib | Cats | Post-operative pain control (orthopedic / spay / neuter, ≥5.5 lbs, ≥4 months of age)
  • Dec 18, 2025 | 141-614 | Anivive Lifesciences, Inc. | LAVERDIA® (verdinexor tablets) | Dogs | Treatment of canine lymphoma
  • Dec 18, 2025 | 141-576 | Dechra, Ltd. | CosACTHen® (cosyntropin injection) | Dogs | Adrenal function evaluation
  • Dec 17, 2025 | 141-619 | Elanco US Inc. | Credelio Quattro™-CA1 (lotilaner + moxidectin + praziquantel + pyrantel) | Dogs | New World screwworm myiasis (New World screwworm / Cochliomyia hominivorax)
  • Dec 5, 2025 | 200-710 | Dechra Veterinary Products LLC | Maropitant Citrate | Dogs and cats | Acute vomiting
  • Oct 24, 2025 | 141-494 | Elanco US Inc. | Credelio™ (lotilaner) | Dogs | Asian longhorned tick + Lyme disease prevention
  • Oct 21, 2025 | 200-825 | Felix Pharmaceuticals Pvt. Ltd. | Clomipramine Hydrochloride Tablets | Dogs | Separation anxiety (as part of a comprehensive behavioral management program)
  • Oct 20, 2025 | 141-581 | Elanco US Inc. | Credelio Quattro™ | Dogs | Asian longhorned tick + Lyme disease
  • Sep 19, 2025 | 200-824 | Felix Pharmaceuticals Pvt. Ltd. | Dexmedetomidine Hydrochloride | Dogs and cats | Sedation + analgesia + preanesthetic medication
  • Sep 19, 2025 | 141-585 | Elanco US Inc. | Zenrelia™ (ilunocitinib) | Dogs | Boxed warning + animal safety warning revisions
  • Aug 28, 2025 | 200-821 | Parnell Technologies Pty. Ltd. | Isoflurane | Horses and Dogs | Anesthesia
  • Aug 14, 2025 | 200-794 | Cronus Pharma | Meloxisol™ (meloxicam oral suspension) | Dogs | Osteoarthritis
  • Aug 5, 2025 | 200-818 | Bimeda Animal Health Ltd. | MoxiCloprid™ (imidacloprid + moxidectin) | Dogs | Heartworm prevention + fleas + mites
  • Jul 21, 2025 | 200-817 | Felix Pharmaceuticals Pvt. Ltd. | Meloxicam Oral Suspension | Dogs | Osteoarthritis
  • Jul 18, 2025 | 200-759 | ZyVet Animal Health, Inc. | Furosemide Tablets | Dogs and Cats | Cardiac edema
  • Jul 10, 2025 | 141-545 | Intervet, Inc. | BRAVECTO® QUANTUM (first approval) | Dogs | 12 months of flea + tick protection (Note: the NADA 141-599 entry on Mar 16, 2026 is a label update, not a new active ingredient)
  • Jul 8, 2025 | 200-815 | Felix Pharmaceuticals Pvt. Ltd. | Cefpodoxime Proxetil Tablets | Dogs | Skin infections

2025 H1 (Jan-Jun) — 6 entries

  • Jun 27, 2025 | 200-814 | Felix Pharmaceuticals Pvt. Ltd. | Methimazole Coated Tablets | Cats | Hyperthyroidism
  • Jun 27, 2025 | 200-813 | Felix Pharmaceuticals Pvt. Ltd. | Clindamycin Hydrochloride Tablets | Dogs | Skin/wound/dental/bone infections
  • Jun 24, 2025 | 200-812 | Qilu Animal Health Products Co., Ltd. | Cefovecin Sodium for Injection | Dogs and Cats | Skin infections
  • May 21, 2025 | 141-581 | Elanco US Inc. | Credelio Quattro™ | Dogs | Hookworm (Ancylostoma caninum) fourth-stage larvae + adults
  • Apr 29, 2025 | 141-600 | Intervet, Inc. | Mometamax Single™ | Dogs | Otitis externa (yeast + bacteria + Pseudomonas)
  • Apr 23, 2025 | 141-554 | Boehringer Ingelheim | NexGard® PLUS | Dogs | Lyme disease prevention
  • Apr 10, 2025 | 141-598 | Dechra, Ltd. | Otiserene® (marbofloxacin + terbinafine + dexamethasone) | Dog | Otitis externa
  • Apr 8, 2025 | 141-521 | Zoetis Inc. | Simparica TRIO® | Dogs | Tapeworm (Dipylidium caninum) prevention
  • Mar 14, 2025 | NADA 141-604 | TriviumVet | felycin-CA1 (sirolimus delayed-release tablets) | Cats | Management of ventricular hypertrophy in subclinical hypertrophic cardiomyopathy (HCM) (LV wall thickness ≥6 mm)

2024 H2 (Nov-Dec) — 5 entries

  • Nov 25, 2024 | NADA 141-532 | Intervet, Inc. | BRAVECTO 1-MONTH (fluralaner) | Dogs | Kills Asian longhorned ticks for 1 month
  • Nov 22, 2024 | NADA 141-452 | Zoetis Inc. | SIMPARICA (sarolaner) | Dogs | Kills Asian longhorned ticks
  • Nov 18, 2024 | ANADA 200-793 | Parnell Technologies Pty. Ltd. | PropofolVet Multidose (propofol injectable emulsion) | Dogs | Induction and maintenance of anesthesia
  • Nov 13, 2024 | NADA 141-502 | Zoetis Inc. | revolution PLUS (selamectin + sarolaner) | Cats | Tapeworm (Dipylidium caninum) prevention
  • Nov 6, 2024 | NADA 141-521 | Zoetis Inc. | SimparicaTRIO (sarolaner + moxidectin + pyrantel) | Dogs | Kills Asian longhorned ticks

Key Company Roll-up (2024-2026)

  • Intervet, Inc. (MSD Animal Health) — 8 BRAVECTO-line entries (incl. PLUS / QUANTUM / 1-MONTH) + NexGard / Numelvi / Mometamax / Vetmedin → dog/cat ectoparasites + anti-inflammatory + cardiovascular
  • Boehringer Ingelheim Animal Health USA, Inc. — NexGard line / Vetmedin line → canine ectoparasites + cardiovascular
  • Elanco US Inc. — Credelio / Credelio Quattro / Zenrelia → canine ectoparasites + dermatology
  • Zoetis Inc. — Simparica / revolution PLUS / SYNOVEX → dog/cat ectoparasites + growth promotion
  • Felix Pharmaceuticals Pvt. Ltd. (Indian generic manufacturer) — Nitenpyram / Atipamezole / Maropitant / Meloxicam / Clindamycin / Methimazole / Cefpodoxime / Clomipramine / Praziquantel → multi-indication generics for dogs and cats
  • Cronus Pharma Specialities India Private Ltd. (Indian generic manufacturer) — Florfinasone / Robenacoxib / Meloxisol → anti-inflammatory generics for dogs and cats
  • TriviumVet — felycin-CA1 (sirolimus, feline HCM) + LIAVIUM-CA1 (pregabalin, canine Chiari) → specialist in rare-disease novel animal drugs
  • Dechra, Ltd. / Dechra Veterinary Products LLC — CosACTHen / Maropitant / Otiserene → dog/cat adrenal / emesis / otic

Key Active Ingredients / New Indications (2024-11 to 2026-06)

  1. Asian longhorned tick (Haemaphysalis longicornis) — 5+ new indications (BRAVECTO / BRAVECTO QUANTUM / BRAVECTO 1-MONTH / Simparica / Simparica TRIO / NexGard) → a rapid response to a newly introduced invasive tick species in the US
  2. Gulf Coast tick (Amblyomma maculatum) — 4 new indications (BRAVECTO / BRAVECTO QUANTUM / BRAVECTO PLUS / NexGard) → differing durations of efficacy: 12 weeks / 12 months / 2 months
  3. felycin-CA1 (sirolimus) — 2025-03: first novel animal drug for subclinical feline HCM (conditionally approved → CA1 suffix), for the management of ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM)
  4. LAVERDIA® (verdinexor) — 2025-12: a new treatment option for canine lymphoma (XPO1 inhibitor)
  5. New World screwworm (Cochliomyia hominivorax) — 2025-12: expanded indication for Credelio Quattro

Slice Navigation

  • Other livestock segments (cattle / horses / sheep / poultry): see 02_livestock_drug_approvals.md (upcoming slice)
  • OASIS import pet food refusal data: see the web/topics/us-2026/fda-oasis/ parallel batch

Source: pdf-raw/us-approvals/fda-recent-approvals-20260205.html + pet-filtered pdf-raw/us-approvals/fda-recent-approvals-pet_20260205.txt · FDA Green Book Recent Animal Drug Approvals

Sources

  • fda-recent-approvals-pet_20260205.txt