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.
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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.
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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.
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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.
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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.
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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).
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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.
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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.
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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.
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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%.
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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.
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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.
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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.
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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.
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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.
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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.
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