FDA New Approvals
The FDA has approved Monoferric (ferric derisomaltose, also known as iron isomaltoside 1000) for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have non-hemodialysis dependent chronic kidney disease.
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The FDA has approved Palforzia (peanut [Arachis hypogaea] allergen powder-dnfp) as treatment for patients with peanut allergy. It is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Palforzia is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial dose escalation may be administered to patients aged 4 through 17 years. Up-dosing and maintenance may be continued in patients 4 years of age and older. Palforzia is to be used in conjunction with a peanut-avoidant diet. Palforzia is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
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The FDA granted accelerated approval to Tazverik (tazemetostat), a methyltransferase inhibitor in for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
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The FDA has approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing proptosis and the eyes to be pushed. The approval represents the first drug approved for the treatment of thyroid eye disease.
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The FDA has approved Valtoco (diazepam) nasal spray in patients aged 6 and older with epilepsy for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity such as seizure clusters and acute repetitive seizures that are distinct from a patient's usual seizure pattern. Valtoco is a proprietary formulation of diazepam incorporating a proprietary transmucosal absorption enhancer.
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FDA New Combinations
The FDA has approved Trijardy XR (empagliflozin/linagliptin/metformin hydrochloride extended-release tablets) to lower blood sugar in adults with type 2 diabetes, along with diet and exercise. Trijardy XR provides three type 2 diabetes medicines in one pill, including Jardiance (empagliflozin), Tradjenta (linagliptin), and metformin hydrochloride extended-release.
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FDA New Indications
The FDA approved Dificid (fidaxomicin) tablets and oral suspension for use in pediatric patients aged 6 months and older for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD). This approval provides an additional safe and effective treatment option as well as a new formulation for this vulnerable pediatric patient population. Dificid tablets were previously approved for the treatment of CDAD in adults aged 18 years and older.
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The FDA has approved a supplemental new drug application for use of Mycamine (micafungin sodium) for injection in children younger than 4 months of age. The indication spans candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses without meningoencephalitis and/or ocular dissemination. Mycamine is the first antifungal drug approved in the US specifically for the treatment of invasive candidiasis in children younger than 4 months of age.
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The FDA has approved an additional indication, reduction of cardiovascular (CV) disease risk, for the once-weekly injectable formulation Ozempic (semaglutide) in the treatment of type 2 diabetes and has added new trial data information to the label of the oral version Rybelsus pertaining to CV safety. The FDA expanded the Ozempic label to include an indication for reducing the risk for major adverse cardiovascular events, including CV death, nonfatal myocardial infarction, or nonfatal stroke in adults with type 2 diabetes who have established CV disease.
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ABH Nature’s Product, Inc., ABH Pharma, Inc., and Stocknutra.com, Inc. Dietary Products
ABH Nature’s Product, Inc, ABH Pharmacy, Inc., and Stocknutra.com, Inc. are conducting a nationwide recall of all lots of dietary supplement products pursuant to a Consent Decree entered by the U.S. District Court for the Eastern District of New York. This recall applies to all dietary supplement products manufactured and sold between January 2013 and November 2019, and all lots of products are included in this recall. These products are being recalled after an FDA inspection found significant violations of current good manufacturing practice regulations.
Learn more about the ABH Nature’s Product, Inc., ABH Pharma, Inc., and Stocknutra.com, Inc. dietary products recall
Efficient Laboratories Rompe Pecho
Efficient Laboratories, Inc. is voluntarily recalling one lot each of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAXliquid. Specifically, they are recalling the following lots: Rompe Pecho EX lot 19F332, exp June 2022, Rompe Pecho CF lot 19H359, exp August 2022, and Rompe Pecho MAX lot 19B42, exp February 2022. These three lots have been found to contain microbial contamination. In rare circumstances, consumption of Rompe Pecho from these lots could result in vomiting and diarrhea. Efficient Laboratories has not yet received any reports of adverse events.
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Fusion IV Pharmaceuticals, Inc dba AXIA Pharmaceutical Sterile Drug Products
Fusion IV Pharmaceuticals, Inc. dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry, to the user level, due to a lack of assurance of sterility. The recalled sterile products have been found to be inconsistent with federal guidelines.
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Bacitracin for Injection
The FDA has requested that all current manufacturers of bacitracin for injection voluntarily withdraw their product from the market. Bacitracin for injection is currently FDA-approved to treat infants with pneumonia and empyema (a collection of pus in the space between the membranes lining the lungs) caused by staphylococci, a type of bacteria, shown to be susceptible to the drug. However, healthcare professionals no longer use bacitracin for injection to treat this condition because other effective FDA-approved treatments are available that do not have the same serious risks, including nephrotoxicity (harm to the kidneys).
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Belviq, Belviq XR Cancer Risk
The FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin). At this time, the cause of the cancer is uncertain, and the FDA states it cannot be concluded that Belviq contributes to the cancer risk. However, the FDA wants to make the public aware of this potential risk. They are continuing to evaluate the clinical trial results and will communicate final conclusions and recommendations when they have completed the review.
Learn more about the risk of cancer with Belviq, Belviq XR
Clozapine Untreated Constipation Warning
The FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to serious bowel complications. This can lead to hospitalization or even death if constipation is not diagnosed and treated quickly.
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NDMA in Metformin
The FDA has posted laboratory results showing N-Nitrosodimethylamine (NDMA) levels in some metformin products approved in the US. The FDA has determined that the levels of NDMA in metformin products tested range from not detectable to low levels. The FDA has not recommended metformin recalls in the US and will continue to monitor NDMA in metformin, along with other drugs products.
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