US Pharm. 2024;49(9):58.

Blood Test for Colorectal Cancer Gets Green Light

A breakthrough in medical testing now allows for colorectal cancer screening with just a simple blood test, promising a more accessible and less invasive way to catch the disease early. The FDA has approved the test, called Shield, which can accurately detect tumors in the colon or rectum about 87% of the time when the cancer is in treatable early stages.

Colorectal cancer is one of the most common types of cancer diagnosed in the United States each year, along with being one of the leading causes of cancer deaths. The condition is treatable in early stages, but about one in three people fails to stay up to date on regular screenings, which should begin at age 45 years.

FDA Approves Amneal’s Potassium Phosphates Injection IV Bags

Amneal Pharmaceuticals, Inc., has announced that it has received approval from the FDA for its new presentation of potassium phosphates in 0.9% sodium chloride injection IV ready-to-use bags. This sterile presentation reduces the compounding steps typically required, making product administration easier for clinicians. The product is available as a single-dose infusion bag and is formulated without preservatives, is natural rubber latex–free, and can be stored at room temperature.

Nalmefene Hydrochloride Autoinjector to Reverse Opioid Overdose Approved

On August 7, 2024, the FDA approved Zurnai, the first nalmefene hydrochloride autoinjector for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients aged 12 years and older. The agency approved the first nasal spray formulation of nalmefene in May 2023.

Nalmefene is an opioid receptor antagonist that is used to treat acute opioid overdose. If nalmefene is administered quickly, it can reverse the effects of opioid overdose, including respiratory depression, sedation, and low blood pressure. The newly approved product delivers 1.5 mg of nalmefene subcutaneously or intramuscularly. Zurnai is a single-dose, prefilled autoinjector and is available only by prescription.

FDA Approves First Nasal Spray for Treating Anaphylaxis

On August 9, 2024, the FDA approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds). Neffy is a single-dose nasal spray administered into one nostril. As with epinephrine injection products, a second dose (using a new nasal spray to administer neffy in the same nostril) may be given if there is no improvement in symptoms or if symptoms worsen.

Crexont Capsules Receives FDA Approval

On August 7, 2024, Amneal Pharmaceuticals, Inc. announced that the FDA approved Crexont (carbidopa and levodopa) extended-release (ER) capsules for the treatment of Parkinson’s disease (PD). Crexont is a novel oral formulation of carbidopa/levodopa that combines both immediate-release granules and ER pellets. Crexont is a prescription medication for the treatment of PD, PD caused by infection or inflammation of the brain, or PD-like symptoms that may result from carbon monoxide or manganese poisoning in adults.

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