April 26, 2024 - FDA Roundup: April 26, 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 published the FDA Voices: “A Milestone in Facilitating the Development of Safe and Effective Biosimilars,” by Sarah Yim, Director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars, Hilary Marston, M.D., M.P.H., and Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research. This week, the FDA approved the 50th biosimilar, reflecting the markedly increased availability of biosimilar products—products that treat a wide range of chronic and severe illnesses, and which have already had an important impact on patient access. Biosimilars are now approved for 15 different reference biologics, and treat illnesses like rheumatoid arthritis, inflammatory bowel disease, some cancers, psoriasis, diabetes, macular degeneration, osteoporosis, and more. The agency has also updated and re-released the Biosimilars Action Plan to reinforce the FDA’s commitment to these important initiatives and to articulate a strategy to further expand biosimilar product availability and utilization.
• Today, the FDA announced that is has finalized Guidance for Industry (GFI) #120:  Veterinary Feed Directive Regulation Questions and Answers, to provide guidance to industry on the requirements of the veterinary feed regulations   (i.e., the Veterinary Feed Directive (VFD) final rule). The VFD final rule outlines the process for authorizing the use of approved animal drugs intended for use in or on the feed of food-producing animals that require veterinary oversight, including medically important antimicrobials when needed for specific animal health purposes. This final guidance also serves as a Small Entity Compliance Guide.
• On Thursday, the FDA announced it has approved the first generic pimobendan for the management of congestive heart failure in dogs. Pimomedin (pimobendan) chewable tablets is approved for the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM). Pimomedin is indicated for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis. Pimomedin is only available by prescription from a licensed veterinarian.
• On Wednesday, the FDA issued an additional warning letter that describes violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S. The warning letter issued to Cardinal Health (firm marketing and distributing plastic syringes made in China within the U.S.) also describes violations related to quality system regulations for syringe products. The FDA expects this firm to fully address the violations described in the warning letter. The FDA will continue efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available. 
• On Tuesday, the FDA posted the Report on the Performance of Drugs and Biologics Firms in Conducting Postmarketing Requirements  and Commitments (PMCs) for FY 2022. The FDA is pleased to report that applicants successfully completed (fulfilled) or released most of the Postmarketing Requirements (PMRs)/Postmarketing Commitments (PMCs) for the previous years reported on in the FY 2022 report. The majority of PMRs/PMCs are progressing according to the original schedule. Overall, few PMRs/PMCs are delayed. The FDA is committed to ensuring that PMRs and PMCs, which further describe the safety, efficacy, and/or optimal use of a drug, are conducted and reported as required. 
• On Tuesday, the FDA approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. Lutetium Lu 177 dotatate received approval for this indication for adults in 2018. This represents the first FDA approval of a radioactive drug, or radiopharmaceutical, for pediatric patients 12 years of age and older with SSTR-positive GEP-NETs. Full prescribing information for Lutathera will be posted here.
• On Tuesday, the FDA granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This represents the first FDA approval of a systemic therapy for the treatment of patients with pediatric LGG with BRAF rearrangements, including fusions. Full prescribing information for Ojemda will be posted here.

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