On Tuesday, the FDA posted warning letters to four companies marketing the unapproved animal drug toltrazuril to treat conditions like coccidiosis and equine protozoal myeloencephalitis (EPM). The companies included All Things Bunnies Inc., Linessa Farms LLC, TotalTotrazuril.com and T
Friday, June 21, 2024
| All Things Bunnies, Inc. | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated | ||||
| Linessa Farms, LLC | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated |
| Premier Manufacturing Products, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| Fancystage Unipessoal, LDA | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | ||||
| Toltrazuril Shop | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated | ||||
| totaltoltrazuril.com | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated |
| Premier Manufacturing Products, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug | ||||
| GFA Production Xiamen Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Aqualex Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Adulterated | ||||
| Landy International | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
Tuesday, June 11, 2024
FDA Approves First Generic Phenylpropanolamine Hydrochloride Chewable Tablets for Use in Dogs
Today the U.S. Food and Drug Administration approved Phenylpropanolamine Hydrochloride chewable tablets for the control of urinary incontinence due to a weakening of the muscles that control urination (urethral sphincter hypotonus) in dogs. This is the first generic phenylpropanolamine hydrochloride chewable tablets for dogs.
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Thursday, June 6, 2024
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