FDA New Approvals
The FDA has approved Alymsys (bevacizumab-maly), a biosimilar referencing Avastin. Alymsys is a vascular endothelial growth factor inhibitor indicated for the treatment of: metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment; and metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
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The FDA has approved Camzyos (mavacamten) 2.5mg, 5mg, 10mg, and 15mg capsules for the treatment of adults with symptomatic NYHA class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms. Camzyos is the first and only FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of obstructive HCM.
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The FDA has approved Epsolay (benzoyl peroxide) cream, 5% for the treatment of inflammatory lesions of rosacea in adults. The benzoyl peroxide in Epsolay is encapsulated within silica-based patented microcapsules. The silica-based shell is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile.
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The FDA has approved Mounjaro (tirzepatide) injection, a once-weekly glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
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The FDA has approved Vivjoa (oteseconazole) capsules, an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential. Vivjoa is the first and only FDA-approved medication for this condition.
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The FDA has approved both Voquezna Triple Pak (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and Voquezna Dual Pak (vonoprazan tablets, amoxicillin capsules), for the treatment of Helicobacter pylori infection in adults. Voquezna treatment regimens contain antibiotics conveniently packaged with vonoprazan, a novel potassium-competitive acid blocker and the first acid suppressant from a new drug class approved in the US in over 30 years.
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FDA New Indications
The FDA has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.
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The FDA has approved Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation with a recommended dose of 4mg once daily for 14 days or until hospital discharge, whichever comes first.
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The FDA has approved Qelbree (viloxazine) extended-release capsules for the treatment of ADHD in children (starting at age 6), adolescents and adults.
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The FDA has approved Rinvoq (upadacitinib) 15mg, once daily, for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.
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The FDA has approved Ultomiris (ravulizumab-cwvz) for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive, which represents 80% of people living with the disease.
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The FDA has approved Veklury (remdesivir) for the treatment of pediatric patients who are aged 28 days or older, weigh at least 3kg, and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death. This approval follows the recent sNDA approval for Veklury for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19.
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The FDA has approved Zerbaxa (ceftolozane/tazobactam) for treatment of complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis, in pediatric patients. Previously, the treatment was only approved for adults.
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FDA New Dosing
The FDA has approved Radicava ORS (edaravone) oral suspension for the treatment of adults with amyotrophic lateral sclerosis (ALS). Radicava ORS is an orally administered version of Radicava, which was originally approved in 2017 as an intravenous infusion to treat amyotrophic lateral sclerosis.
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Fagron SyrSpend SF Cherry
Fagron Inc. is voluntarily recalling two lots of SyrSpend SF Cherry to the hospital, pharmacy, and distributor level out of an abundance of caution. The affected lots are potentially contaminated with Burkholderia gladioli.
Learn more about the Fagron SyrSpend SF Cherry recall
Pfizer is voluntarily recalling five lots of Accupril (quinapril HCl) tablets to the patient (consumer/user) level, due to the presence of a nitrosamine, N-nitroso-quinapril, observed in recent testing above the acceptable daily intake level.
Learn more about the Pfizer Accupril recall
Artri and Ortiga Products
The FDA is warning consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to potentially dangerous hidden active drug ingredients not listed on the product label. The FDA urges consumers taking these products to immediately talk to their healthcare professional to safely discontinue use of the product because suddenly stopping these drugs may be dangerous.
Learn more about the Artri and Ortiga products alert
The FDA approved a modification to the Bosentan Risk Evaluation and Mitigation Strategy (REMS) program on April 29, 2022. Beginning June 27, 2022, system changes for healthcare professionals will go into effect.
Learn more about the Bosentan REMS alert
Drug Depot (dba APS Pharmacy) Compounded Drugs
The FDA is alerting patients, healthcare professionals, veterinarians, and animal owners/caretakers about a voluntary recall by Drug Depot, LLC, dba APS Pharmacy, of certain unexpired compounded drugs due to a lack of sterility assurance.
Learn more about the Drug Depot (dba APS Pharmacy) compounded drugs alert