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  • FDA Drug Updates

    FDA New Approvals

    Accrufer

    The FDA approved Accrufer (ferric maltol) for iron deficiency anemia in adults. Accrufer is supplied in a capsule formulation containing 30mg of iron, as ferric maltol. Accrufer offers an alternative to intravenous iron for patients that cannot tolerate salt-based oral iron therapies or for patients in which infusion iron therapy is not an ideal option. Learn more about Accrufer

    Inrebic

    The FDA has approved Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. Inrebic has a Boxed Warning for serious and fatal encephalopathy, including Wernicke's. Learn more about Inrebic

    Nubeqa

    The FDA approved Nubeqa (darolutamide) for non-metastatic castration-resistant prostate cancer. The recommended dose of Nubeqa is 600mg (two 300mg tablets) administered orally twice daily with food. Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy. Learn more about Nubeqa

    Pretomanid

    The novel compound Pretomanid was approved by the FDA for treating some drug-resistant forms of tuberculosis (TB). The new drug was approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) as part of a three-drug, six-month, all-oral regimen for the treatment of people with extensively drug-resistant TB or multidrug-resistant TB who are treatment-intolerant or non-responsive. Pretomanid is a new chemical entity and a member of a class of compounds known as nitroimidazooxazines. Learn more about Pretomanid

    Rinvoq

    The FDA has approved Rinvoq (upadacitinib), a 15mg, once-daily oral Janus kinase inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Learn more about Rinvoq

    Rozlytrek

    The FDA has approved Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer. The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and pediatric patients aged 12 and older with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. Learn more about Rozlytrek

    Turalio

    The FDA granted approval for Turalio (pexidartinib) capsules as treatment of adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not responsive to improvement with surgery. The prescribing information for Turalio includes a Boxed Warning to advise healthcare professionals and patients about the risk of serious and potentially fatal liver injury. Healthcare professionals should monitor liver tests prior to beginning treatment and at specified intervals during treatment. Learn more about Turalio

    Wakix

    The FDA approved Wakix (pitolisant) for the treatment of excessive daytime sleepiness in adult patients with narcolepsy. Wakix is the first narcolepsy treatment that is not scheduled as a controlled substance. Wakix, a first-in-class medication, is a selective histamine 3 receptor antagonist/inverse agonist that works through a novel mechanism of action to increase the synthesis and release of histamine, a wake-promoting neurotransmitter in the brain. It is administered orally once daily in the morning upon waking. Learn more about Wakix

    Xenleta

    The FDA has approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia. Xenleta is available for oral (600mg every 12 hours) and IV (150mg every 12 hours) administration with a short 5- to 7-day course of therapy. Learn more about Xenleta

    FDA New Indications

    Clenpiq

    The FDA has approved Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for use in adults and children aged 9 years and older. The combination of active ingredients in Clenpiq form magnesium citrate, an osmotic laxative, indicated for cleansing of the colon as a preparation for colonoscopy. Learn more about Clenpiq

    Gadavist

    The FDA has approved Gadavist (gadobutrol), the gadolinium-based magnetic-resonance (MR) imaging contrast agent, for myocardial perfusion studies in adults with known or suspected coronary artery disease. Gadavist is the first and only contrast agent FDA approved for use in cardiac MR. Learn more about Gadavist

    Keytruda

    The FDA approved Keytruda (pembrolizumab) for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus whose tumors express PD-L1 (combined positive score ≥10), as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy. Learn more about Keytruda

    Otezla

    The FDA has approved the use of Otezla (apremilast) 30mg twice daily for the treatment of adults with oral ulcers associated with Behçet’s disease. Otezla is an oral phosphodiesterase-4 inhibitor that decreases proinflammatory mediators and increases anti-inflammatory mediators. It is the only FDA-approved treatment for oral ulcers associated with Behçet’s disease. Learn more about Otezla

    FDA Recalls

    Ridge Properties DBA Pain Relief Naturally Topical Cream and Liquid Gel Products

    Ridge Properties DBA Pain Relief Naturally is voluntarily recalling 4 lots of 4% lidocaine topical cream and liquid gel products sold at the consumer level. FDA analysis has found these products to have microbiological contamination and the potency is higher than the labeled amount for lidocaine. Learn more about the Ridge Properties DBA Pain Relief Naturally topical cream and liquid gel products recall

    Relpax

    Pfizer Inc. is voluntarily recalling Relpax (eletriptan hydrobromide) 40mg tablets, lots AR5407 and CD4565, to the patient level. Pfizer Inc. initiated this recall because these product lots may not meet Pfizer's in-house microbiological specification for the potential presence of genera Pseudomonas and Burkholderia. Learn more about the Relpax recall

    FDA Alerts

    Curaleaf Unapproved Cannabidiol Products

    The FDA issued a warning to Curaleaf for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain, and pet anxiety, among other conditions or diseases. According to the FDA, Curaleaf used product webpages, its online store, and social media websites to make unfounded claims about more than a dozen different CBD products. Learn more about the Curaleaf unapproved CBD products warning

    Entacapone Medications

    FDA review of additional data found no increased risk of prostate cancer with the use of entacapone to treat Parkinson's disease. The FDA conducted this review after an earlier trial suggested this possible risk. As a result, FDA recommendations for using Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa) will remain the same in the prescribing information. Learn more about entacapone medications

    Miracle Mineral Solution

    The FDA is warning consumers not to purchase or drink a product sold online as a medical treatment due to a recent rise in reported health issues. Since 2010, the FDA has warned consumers about the dangers of Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide Protocol, Water Purification Solution, and other similar products. Miracle Mineral Solution has not been approved by the FDA for any use, but these products continue to be promoted on social media as a remedy for treating autism, cancer, HIV/AIDS, hepatitis and flu, among other conditions. However, the solution, when mixed, develops into a dangerous bleach which has caused serious and potentially life-threatening side effects. Learn more about the Miracle Mineral Solution consumer warning