Wednesday, January 15, 2025
| HDFrenchies LLC dba Bully Baum | Center for Veterinary Medicine | New Animal Drug/Adulterated | ||||
| Veterinary Select Formula dba Allergic Pet | Center for Veterinary Medicine | New Animal Drug/Adulterated | ||||
| Intermarket Industries Inc. dba Doc Ackerman Pet Products | Center for Veterinary Medicine | New Animal Drug/Adulterated | ||||
| Energetic Essences, LLC dba Pet Essences | Center for Veterinary Medicine | New Animal Drug/Adulterated | ||||
| Indoco Remedies Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| XO Biologix, LLC | Center for Biologics Evaluation and Research (CBER) | Unappro |
“ The FTC released its second interim report on pharmacy benefit managers on Tuesday, claiming that CVS Caremark, Express Scripts and OptumRx dramatically markup specialty generic drugs to affiliated pharmacies, reaping $7.3 billion in excess revenue.”
Tuesday, January 14, 2025
On Monday, the FDA published the blog, “FDA Spearheads Global Efforts on Informal Markets and Substandard/Falsified Medical Products.” This blog is the latest in the “From A Global Perspective” series and discusses the FDA’s role in leading WHO efforts to address knowledge gaps regarding the global distribution of substandard and falsified medical products through informal/unregulated markets.
Today, the FDA’s Center for Veterinary Medicine issued a Dear Veterinarian letter alerting practitioners to the possibility of burns associated with the use of Megadyne grounding pads in animal surgical patients.
Wednesday, January 8, 2025
| Evolution Pets LLC | Center for Veterinary Medicine | New Animal Drug/Adulterated | ||||
| HDFrenchies LLC dba Bully Baum | Center for Veterinary Medicine | New Animal Drug/Adulterated | ||||
| Nutrition Strength Ltd. | Center for Veterinary Medicine | New Animal Drug/Adulterated | ||||
| Veterinary Select Formula dba Allergic Pet | Center for Veterinary Medicine | New Animal Drug/Adulterated | ||||
| Intermarket Industries Inc. dba Doc Ackerman Pet Products | Center for Veterinary Medicine | New Animal Drug/Adulterated | ||||
| Energetic Essences, LLC dba Pet Essences | Center for Veterinary Medicine | New Animal Drug/Adulterated | ||||
| Indoco Remedies Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| XO Biologix, LLC | Center for Biologics Evaluation and Research (CBER) | Unapproved New Drugs/Adulterated | ||||
| Candymar Produce Inc | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Bhargava Phytolab Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceutical/API/Adulterate |
Tuesday, January 7, 2025
- Final Guidance for Industry: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
- Final Guidance for Industry: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Final Guidance for Industry: Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers
FDA Warns Six Sellers of Unapproved Seizure Drugs for Animals
Today, the U.S. Food and Drug Administration posted warning letters sent to six firms selling unapproved drugs that claim to treat and control seizures in dogs and cats.
The unapproved products were sold on the firm’s websites, social media pages and Amazon shops without a prescription or other veterinary oversight. Animal drugs used to treat and control seizures are not safe for animal use except under the professional supervision of a licensed veterinarian because a veterinarian’s specialized training and experience is needed to properly diagnose the condition and manage the health of animals with seizure disorders. Many health problems can cause seizures in animals, including genetic disorders, anemia, head trauma, liver disease, diabetes, cancer and exposure to toxins.
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Thursday, January 2, 2025
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