FDA New Approvals
The FDA has approved Furoscix (furosemide) injection, a proprietary formulation of furosemide delivered via an on-body infusor for the treatment of congestion due to fluid overload in adults with NYHA class II/III chronic heart failure. Furoscix is not indicated for emergency situations or in patients with acute pulmonary edema. Furoscix Infusor will deliver only an 80mg dose. Furoscix is the first and only FDA-approved subcutaneous loop diuretic that delivers IV equivalent diuresis at home via the Furoscix Infusor.
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The FDA has approved Tecvayli (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody. Tecvayli is a first-in-class, bispecific T-cell engager antibody administered as a subcutaneous treatment.
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The FDA has approved Vemlidy (tenofovir alafenamide) 25mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients aged 12 years and older with compensated liver disease. Vemlidy is a novel, targeted prodrug of tenofovir that was previously approved by the FDA in 2016 as a once-daily treatment for adults with chronic HBV infection with compensated liver disease.
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FDA New Indications
The FDA has approved Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed; Tdap) for immunization during the third trimester of pregnancy to help prevent pertussis (whooping cough) in infants younger than two months.
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The FDA has approved the oral MEK inhibitor drug Cotellic (cobimetinib) for the treatment of adult patients with the family of blood diseases known as histiocytic neoplasms. These diseases include Erdheim-Chester disease, Rosai-Dorfman disease, and Langerhans cell histiocytosis. Cobimetinib is an oral inhibitor of MEK1 and MEK2, currently approved to treat melanoma.
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The FDA has approved an expanded indication for DaTscan (ioflupane I 123 injection) for use in patients with suspected Dementia with Lewy Bodies. This new indication is in addition to its use with single photon emission computed tomography imaging to visualize dopamine transporters in the brains of adult patients with suspected Parkinsonian syndromes.
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The FDA has approved a label expansion for Oxlumo (lumasiran), an RNAi therapeutic administered via subcutaneous injection, now indicated for the treatment of primary hyperoxaluria type 1 to lower urinary oxalate and plasma oxalate levels in pediatric and adult patients.
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The FDA has approved Rinvoq (upadacitinib) 15mg, once daily, an oral therapy, for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy. This additional indication follows the FDA approval of Rinvoq in April of this year for adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers, making it the first and only JAK inhibitor that is approved for both conditions.
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FDA New Combinations
Imjudo with Imfinzi
The FDA has approved Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) for the treatment of adult patients with unresectable hepatocellular carcinoma. The novel dose and schedule of the combination includes a single dose of the anti-CTLA-4 antibody Imjudo 300mg added to the anti-PD-L1 antibody Imfinzi 1500mg, followed by Imfinzi every four weeks. It is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).
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Aurobindo Quinapril and HCTZ
Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two lots of quinapril and HCTZ tablets USP 20mg/12.5mg (lots QE2021005-A and QE2021010-A, expiry 1/23), to the consumer level, due to presence of nitrosamine drug substance related impurity, N-nitroso-quinapril, above the proposed interim limit. Aurobindo Pharma USA, Inc. began shipping the subject batches, QE2021005-A and QE2021010-A, to customers nationwide in May 2021.
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Exela Pharma Sciences Sodium Bicarbonate
Exela Pharma Sciences is voluntarily recalling 49 lots of sodium bicarbonate injection, USP, 8.4%, 50mEq/50mL vial, 20-count carton, to the consumer level. The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. Exela has received five reports of flying glass injuring skin, eye, and/or other parts. There have been no reports of sterility failures.
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Mylan Institutional Octreotide Acetate
Mylan Institutional is voluntarily recalling lot AJ21002, exp 3/2024, of octreotide acetate injection, 500mcg/mL, packaged in a carton of ten 1mL syringes. This lot is being recalled at the user (hospital/pharmacy) level due to a product complaint of the presence of glass particles in a syringe.
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