FDA approves ProHeart 12July 8, 2019The U.S. Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) has approved ProHeart 12 (moxidectin) extended release injectable suspension for dogs one year and older.
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FDA updates on potential connection between certain diets and canine DCMJuly 3, 2019The U.S. Food and Drug Administration (FDA) is continuing its investigation into certain diets and a heightened risk of canine dilated cardiomyopathy (DCM), and for the first time, has named the brands most frequently linked to the condition.
Aratana Therapeutics' Nocita 10 ml gets FDA approvalJune 13, 2019Aratana Therapeutics announced the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) has approved an additional vial size (10 ml) of Nocita. "Since its launch in 2016, Nocita has drastically changed veterinary multimodal pain management protocols because it safely and effectively controls pain in patients for up to 72 hours following certain canine and feline surgeries," says Aratana Therapeutics chief development officer, Ernst Heinen, DVM, PhD. "Ultimately, we believe a smaller vial size may allow for expanded use and improve the level of care veterinarians provide for certain painful surgeries." Nocita, which is currently available in a 20-ml vial size, is a local postoperative analgesia for cranial cruciate ligament surgery in dogs and a peripheral nerve block following owner-elected onychectomy (declawing) in cats. The smaller vial size is expected to be made commercially available in fall 2019.
Norbrook Laboratories voluntarily recalls veterinary injectable drug productsMay 30, 2019Norbrook Laboratories is recalling 34 lots of veterinary injectable drug products over concerns related to sterility assurance. The U.K.-based company says products tested, released, and distributed within the U.S. were manufactured on an aseptic line, which did not pass process simulation tests. The recall was made as a precautionary measure, as according to Norbrook, no batches of product have been identified to contain microorganisms. The following products have been recalled: Carprieve Injection, CarproJect Injection, Levafen Injection, and OstiFen Injection (carprofen; 50 mg/mL). They are nonsteroidal anti-inflammatory drugs (NSAIDs) for the pain and inflammation relief associated with osteoarthritis and control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs Loxicom Injection, EloxiJect Injection, and OstiLox Injection (meloxicam; 5 mg/mL) are NSAIDs used for the relief of pain and inflammation connected with orthopedic surgery, ovariohysterectomy, and castration in dogs and cats Enroflox Injection for Dogs 2.27% and EnroSite Injection for Dogs 2.27% (enrofloxacin; 22.7 mg/mL) are used for the management of diseases in dogs associated with bacteria susceptible to enrofloxacin Enroflox 100 Injection (enrofloxacin; 100 mg/mL) is an antimicrobial used for the treatment and control of bovine respiratory disease, for the treatment and control of swine respiratory disease, …
FDA announces proposals to prevent failures in surgical and implantable staplesApril 29, 2019The U.S. Food & Drug Administration (FDA) says it is proposing ways to better protect patients from the malfunctions, injuries, and deaths associated with surgical and implantable staples. The review comes after the FDA alerted public and health-care professionals to concerns over surgical staplers for internal use and implantable surgical staples. The alert was prompted as the result of the agency's analysis showing that from Jan. 1, 2011 to Mar. 31, 2018, it received more than 41,000 medical device reports pertaining to over 32,000 malfunctions, approximately 9,000 serious injuries, and 366 patient deaths. The most reported problems referred to staple lines opening, malformation of staples, misfiring and difficulty in firing of staples, stapler failure, and misapplied staples. These devices are commonly used in veterinary settings. The FDA's new proposals include: 1) Reclassifying surgical staplers for internal use to a higher-risk category, requiring the review and clearance of a premarket notification submission prior to marketing. The staples would be reclassified from Class I (low risk) to Class II (moderate risk) medical devices with special controls. This would require mandatory performance testing of various mechanical features, demonstration of usability and labeling comprehension such as assessing health-care professionals' ability to properly select …
FDA approves treatment for urinary incontinence in dogsApril 2, 2019PROIN ER, a tablet for the control of urinary incontinence in dogs, has been approved by the U.S. Food and Drug Administration (FDA). The drug treats urethral sphincter hypotonus, which occurs due to a dog's age and weakening muscles in the urethra. PROIN Chewable Tablets have already been approved by the FDA; however, they are to be administered twice a day, whereas PROIN ER is a once-a-day extended-release formulation. The effectiveness of PROIN ER was observed in a clinical study comprising 119 dogs that had been previously diagnosed with urethral sphincter hypotonus and had been taking PROIN Chewable Tablets. The timeline of the clinical study went as follows: • For the first week, the owners documented whether the dog received the PROIN Chewable Tablet doses and noted the number of urinary accidents the dog had; • Dogs were then given PROIN ER for the first 28 days and the owners proceeded to take note of how many accidents occurred in a day; • In the fourth week, the number of urinary accidents was compared to the first week. It was found 75 of the 104 dogs who completed the study had no accidents on either tablet;
FDA investigating elevated levels of vitamin D in Hill's recallMarch 22, 2019The U.S. Food and Drug Administration (FDA) says it is looking into the presence of elevated levels of vitamin D in Hill's Pet Nutrition canned dog food. The news comes after the pet food company issued an expanded recall on Wednesday for 85 total lots of 33 varieties (SKUs) of its canned dog foods after receiving complaints dogs eating the food were experiencing vitamin D toxicity. Currently, the recall is only for canned dog food and does not affect canned cat food, dry food (kibble), or treats. Hill's says the products in both recalls were made with the same vitamin premix. According to the FDA, the recall was expanded after it requested that Hill's test samples of food it had produced that were not part of the original recall. Hill's conducted that testing and issued the expanded recall of 19 additional products of canned dog food. In a letter sent to veterinarians, Hill's Pet Nutrition vice president and general manager, Jesper Nordengaard said, "We understand this recall has caused pet parents considerable anxiety and that the well-being of their pets may have been affected. We are also aware of the disruption and difficulty this has caused you and your …
FDA finds potential link between diet and canine DCMFebruary 20, 2019According to reports investigated by the U.S. Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM), a large proportion of diets in canine DCM cases—both grain-free and grain-containing—include peas and/or lentils in various forms as a main ingredient.
FDA approves new drug for diabetic dogsFebruary 12, 2019A new drug for managing diabetes mellitus in dogs has been approved for use in the U.S.
Lystn fires back at FDA's Salmonella warning against its dog foodJanuary 18, 2019Lystn has issued a response to the U.S. Food Drug and Administration’s (FDA’s) warning notice against its dog food products.
