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  • FDA Drug Updates

    FDA New Approvals


    The FDA approved Asparlas (calaspargase pegol-mknl), an asparagine-specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia in pediatric and young adult patients aged 1 month to 21 years. This new product provides for a longer interval between doses compared to other available pegaspargase products. Learn more about Asparlas


    The FDA has approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients aged 2 years and older. The approved recommended dosage of Elzonris is 12mcg/kg as an intravenous infusion over 15 minutes once daily on days 1 to 5 of a 21-day cycle. The dosing period may be extended for dose delays up to day 10 of the cycle. Prior to this approval there was not an FDA approved therapy for BPDCN. Learn more about Elzonris


    The FDA has approved Inbrija (levodopa) inhalation powder for intermittent treatment of "off" episodes in people with Parkinson’s disease who are already taking an oral carbidopa-levodopa regimen. Learn more about Inbrija

    ProAir Digihaler

    The FDA approved ProAir Digihaler (albuterol sulfate), the first and only digital inhaler with built-in sensors that connect to a companion mobile application that can monitor usage as well as strength of the user's inhalation. ProAir Digihaler is approved for use in people aged 4 years and older to treat or prevent bronchospasm in individuals with reversible obstructive airway disease and to prevent exercise-induced bronchospasm. Learn more about ProAir Digihaler


    The FDA has approved Ultomiris (ravulizumab-cwvz) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease. PNH is a rare acquired disorder that leads to hemolysis. Healthcare providers are advised to use caution when administering Ultomiris to patients with any other systemic infection. Learn more about Ultomiris


    The FDA approved Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, Haemophilus B conjugate [meningococcal protein conjugate] and hepatitis B [recombinant]) vaccine. Vaxelis is indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. Vaxelis is approved for use as a 3-dose series in children aged 6 weeks through 4 years (prior to the 5th birthday). Learn more about Vaxelis

    FDA New Indications


    The FDA granted accelerated approval to Keytruda (pembrolizumab) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. Learn more about Keytruda


    The FDA approved Lynparza (olaparib) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy, as detected by an FDA-approved companion diagnostic test. Learn more about Lynparza


    The FDA approved Nplate (romiplostim) for pediatric patients aged 1 year and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate is a thrombopoietin (TPO) receptor agonist that mimics the body's natural TPO and is designed to increase platelet counts in patients with chronic ITP. Learn more about Nplate

    FDA Recalls

    Asclemed USA Inc Dyural-40 and Dyural-80 Injectable Convenience Kits

    Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled sodium chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex. The products are Dyural-40 convenience kits packaged in plastic trays and Dyural-80 convenience kits packaged in plastic trays, containing sodium chloride, USP, 0.9%. Learn more about the Asclemed USA Inc Dyural-40 and Dyural-80 recall

    Aurobindo Pharma USA, Inc. Amlodipine/Valsartan, Valsartan/HCTZ, and Valsartan Tablets

    Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of amlodipine/valsartan tablets USP, valsartan/HCTZ tablets, USP and valsartan tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine. Learn more about the Aurobindo Pharmacy USA, Inc. recall

    Happy Together, Inc. Rhino 5k Capsules

    Happy Together, Inc. is voluntarily recalling all lots within expiry of the Rhino 5k capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and tadalafil. Learn more about the Happy Together, Inc. Rhino 5k capsule recall

    Lupin Pharmaceuticals, Inc. Ceftriaxone 250mg, 500mg, 1g, and 2g Injections

    Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of ceftriaxone for injection, USP, 250mg, 10 lots of ceftriaxone for injection, USP, 500mg, 24 lots of ceftriaxone for injection, USP, 1g and 3 lots of ceftriaxone for injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials. Learn more about the Lupin Pharmaceuticals, Inc. ceftriaxone 250mg, 500mg, 1g, and 2g injections recall

    Sun Pharmaceutical Industries, Inc. Vecuronium Bromide 10mg and 20mg Injection

    Sun Pharmaceutical Industries, Inc. is voluntarily recalling three lots of vecuronium bromide for injection, 10mg (lyophilized powder), and one lot of vecuronium bromide for injection, 20mg (lyophilized powder) to the hospital level. The vecuronium bromide for injection has been found to contain particulate matter identified as glass. Learn more about the Sun Pharmaceutical Industries, Inc. vecuronium bromide 10mg and 20mg injection recall

    Torrent Pharmaceuticals Limited Losartan 100mg Tablets

    Torrent Pharmaceuticals Limited is voluntarily recalling 10 lots of losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine. Learn more about the Torrent Pharmaceuticals Limited losartan tablet recall

    FDA Alerts

    Increased Risk of Ruptures or Tears in the Aorta with Fluoroquinolones

    An FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection. Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available. Learn more about the risk of aortic ruptures or tears with fluoroquinolones