FDA Roundup: August 13, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA posted two warning letters issued to BullyKamp Products LLC and Top Dog Pet Store LLC dba The Bulldog Cartel, for marketing unapproved animal drugs intended for dogs, in violation of federal law. Because the unapproved animal drugs have not been submitted to the FDA for review, the agency is unable confirm whether they are safe, effective, properly manufactured, or if they contain the ingredients stated on the labels, in the quantities stated on the labels.
• On Monday, the FDA announced that it will hold a public meeting on October 16, 2024, titled, “Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub.” The meeting is to discuss the establishment of the Rare Disease Innovation Hub (or “the Hub”), which will enhance collaboration and cooperation across the FDA’s Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research, as well as other centers and offices across the FDA, to advance rare disease therapies. The meeting, which will be facilitated by the Reagan-Udall Foundation, will provide those in the rare disease community the opportunity to provide input on the priorities of the Hub. Information on the meeting, including topics for discussion and how to register, may be found here.
• On Friday, the FDA approved Yorvipath (palopegteriparatide) injection for subcutaneous use in adults with hypoparathyroidism. Yorvipath was not studied in adults with acute post-surgical hypoparathyroidism. Hypoparathyroidism is a rare disease most often caused by damage to the parathyroid glands from surgery or autoimmune disease. Patients with hypoparathyroidism have low levels of parathyroid hormone (PTH), which leads to hypocalcemia (blood calcium levels that are too low). The effectiveness of Yorvipath was evaluated in a 26-week, randomized, double-blind, placebo-controlled trial that enrolled 82 adults with hypoparathyroidism. At the end of the trial, 69% of the patients in the Yorvipath group compared to 5% of the patients in the placebo group were able to maintain their calcium level in the normal range, without needing active vitamin D and high doses of calcium (calcium dose ≤ 600 mg/day). Consult the prescribing information for more details about Yorvipath, including the risks.
• On Thursday, the FDA updated the advisory, Investigation of Illnesses: Diamond Shruumz-Brand Chocolate Bars, Cones, and Gummies, to include additional testing results for a number of Diamond Shruumz-brand Chocolate Bar samples. To date, the FDA has test results available for 19 samples of the Chocolate Bars and one raw ingredient that was reportedly used in the manufacturing of some Diamond Shruumz-brand products. Additional information can be found in our advisory. 

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