FDA

FDA approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Merilog, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial. Merilog is the third insulin biosimilar product approved by the FDA and joins the two long-acting insulin biosimilar products approved in 2021 by the FDA. Approval of biosimilar products can increase patient access to safe and effective treatment options. Like Novolog, Merilog should be administered within five to ten minutes prior to the start of a meal. Merilog is administered subcutaneously (under the skin) by injection into the stomach, buttocks, thighs or upper arms. Dosing of Merilog should be individualized and adjusted based on the patient’s needs. Merilog may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions and hypokalemia (low potassium in blood). Other common side effects may include injection site reactions, itching, rash, lipodystrophy (skin thickening or pitting at the injection site), weight gain and swelling of hands and feet. Learn more in the FDA-approved prescribing information below and at: https://lnkd.in/ex3rSfQ3

FDA qualifies a drug development tool to facilitate clinical trial research on alcohol use disorder: https://lnkd.in/d6RrpuBx This tool provides a new endpoint option for researchers and drug developers alongside abstinence and no heavy drinking days. With this qualification, investigators can now determine if their proposed treatment works as they expect based on whether it reduced risk drinking levels by two levels in clinical trials.

FDA approves second biosimilars to Prolia and Xgeva (denosumab): https://lnkd.in/eJgc8mnf

FDA posted a digital catalogue of nearly 1,000 historical documents pertaining to monograph drugs: https://lnkd.in/gfj8xgt7 This catalogue includes a list of documents that were only accessible as paper documents prior to the passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

FDA approved a treatment for complicated intra-abdominal infections (cIAI) in adult patients who have limited or no alternative options. To learn more, view the prescribing information: https://lnkd.in/evHDMbfb For additional information on antibacterial susceptibility test interpretive criteria, visit: https://lnkd.in/e8nCKPMD

The Louisiana Department of Public Health has issued a recall for certain oysters harvested from Louisiana Area 3 from 1/10/2025 - 2/4/2025. The oysters were shipped to distributors and retailers in AL, FL, LA, MD, MS, NC, and TX and may have been distributed to other states. https://lnkd.in/edA4xq6f The FDA is advising restaurants and food retailers not to serve or sell and to dispose of, and consumers not to eat, these oysters following the instruction provided below because they may be contaminated with norovirus.

OUTBREAK: Salmonella investigation in Sweet Cream-Brand Mini Pastries with a best buy date of June 17 – November 15, 2025. Recalled mini pastries were distributed in FL, NJ, NY, and PA to food service locations such as hotel cafes, bakeries, institutions, and restaurants. The firm has directly notified customers who received the recalled product, and the recalled product should no longer be available for sale. This advisory will be updated as needed. https://lnkd.in/eEuxVdgb

The FDA is committed to protecting and promoting public health by collecting information on breast implant safety and effectiveness and sharing updates. Check out the latest on breast implant medical device reports through June 30, 2024, for systemic symptoms and BIA-ACL, latest patient brochures and labeling. https://lnkd.in/ezZdmzw

FDA is alerting patients who use diabetes devices as well as their caregivers, of a safety concern regarding alerts from continuous glucose monitors (CGMs) and other diabetes devices not being delivered or not being heard on their compatible smartphones. In some cases, missing these alerts may have contributed to serious harm including severe hypoglycemia, severe hyperglycemia, diabetic ketoacidosis, and death. Find out more: https://lnkd.in/e_BcR83u

FDA approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain. This is the first drug to be approved in this new class of pain management medicines. Journavx is contraindicated for concomitant use with strong CYP3A inhibitors. Additionally, patients should avoid food or drink containing grapefruit when taking Journavx. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Reduce dosage in patients with moderate hepatic impairment as use may increase the risk of adverse reactions. The most common adverse reactions in study participants who received Journavx were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. Learn more in the FDA-approved prescribing information below and at: https://lnkd.in/dUUs3fxB.