The FDA has approved Auvelity (bupropion HCl/dextromethorphan HBr) extended-release tablets for the treatment of major depressive disorder (MDD) in adults. Auvelity is the first and only rapid-acting oral medicine approved for the treatment of MDD with labeling of statistically significant antidepressant efficacy compared to placebo starting at one week. Auvelity is the first and only oral N-methyl D-aspartate receptor antagonist approved for the treatment of MDD.
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The FDA has approved Daxxify (daxibotulinumtoxinA-lanm) for injection for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults. Daxxify is the first and only neuromodulator stabilized with peptide exchange technology and is free of both human serum albumin and animal-based components.
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The FDA has approved Haloette (ethinyl estradiol/etonogestrel) vaginal hormonal contraceptive ring. Haloette contraceptive is a generic version of Nuvaring, a combined hormonal contraceptive flexible ring that combines etonogestrel and ethinyl estradiol and is indicated for the prevention of pregnancy. Commercial launch of Haloette is expected by early 2023.
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Juvéderm Volux XC
The FDA has approved Juvéderm Volux XC for the improvement of jawline definition in adults aged 21 or older with moderate to severe loss of jawline definition.
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The FDA has approved Konvomep (omeprazole/sodium bicarbonate) for oral suspension. Konvomep is approved for the treatment of active benign gastric ulcer and reduction of risk of upper gastrointestinal bleeding in critically ill patients.
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The FDA has approved Sotyktu (deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
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The FDA has approved Spevigo (spesolimab) intravenous injection for generalized pustular psoriasis (GPP) flares in adults. Spevigo is a novel, selective antibody that blocks the activation of the interleukin-36 receptor, a signaling pathway within the immune system shown to be involved in the pathogenesis of GPP.
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The FDA has approved the pegfilgrastim biosimilar Stimufend for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Product launch in a prefilled syringe is planned for early next year.
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The FDA has approved Xenpozyme (olipudase alfa-rpcp) for the treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. Xenpozyme is the first therapy indicated specifically for the treatment of ASMD and is currently the only approved treatment for this disease.
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The FDA has approved Zynteglo (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy custom-designed to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell transfusions.
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The FDA has approved the use of Imbruvica (ibrutinib) for the treatment of pediatric patients aged one year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. The approval is the first pediatric indication for Imbruvica, marking the twelfth FDA approval for Imbruvica and the first Bruton's tyrosine kinase inhibitor treatment approved for a pediatric patient population. This approval also marks the first approved treatment option for children aged under 12 years suffering from cGVHD.
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The FDA has approved expanded use of Orkambi (ivacaftor/lumacaftor) to include children with cystic fibrosis aged 12 to <24 months who are homozygous for the F508del mutation (F/F genotype) in the cystic fibrosis transmembrane conductance regulator gene. Orkambi was previously approved by the FDA for use in people with cystic fibrosis aged 2 years and older with two copies of the F508del mutation.
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The FDA has approved Pemazyre (pemigatinib), a selective fibroblast growth factor receptor inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement. This is the second indication for Pemazyre, which received accelerated FDA approval in 2020 for adults with previously treated, unresectable, locally advanced, or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement.
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Hospira Propofol Injectable Emulsion
Hospira, a Pfizer company, is voluntarily recalling one lot of propofol injectable emulsion (containing benzyl alcohol), 100mL single patient use glass flip-top vial; lot EA7470, to the user level, due to visible particulates observed in two vials during annual examination of retention samples.
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