FDA New Approvals
The FDA has approved Adstiladrin (nadofaragene firadenovec-vncg), a novel adenovirus vector-based gene therapy, for the treatment of adult patients with high-risk, Bacillus Calmette-Guerin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.
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The FDA has approved Airsupra (albuterol/budesonide) for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. Airsupra is a first-in-class, pressurized metered-dose inhaler, fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist, and budesonide, an anti-inflammatory inhaled corticosteroid.
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The FDA has approved Briumvi (ublituximab-xiiy) for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
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The FDA has approved biosimilar Idacio (adalimumab-aacf), a tumor necrosis factor blocker for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product, Humira (adalimumab).
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The FDA has approved Iyuzeh (latanoprost) ophthalmic solution 0.005% for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Iyuzeh is the first and only clinically proven formulation of latanoprost available in the US that is preservative-free.
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The FDA has approved Krazati (adagrasib), a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
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The FDA has approved Leqembi (lecanemab-irmb) 100mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta for the treatment of Alzheimer’s disease.
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The FDA has approved Lunsumio (mosunetuzumab-axgb) for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate.
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The FDA has approved Nexobrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns. NexoBrid can be applied in up to two applications of four hours each.
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The FDA has approved Olpruva (sodium phenylbutyrate) for oral suspension in the US for the treatment of certain patients living with urea cycle disorders involving deficiencies of carbamoyl phosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase.
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The FDA has approved Sunlenca (lenacapavir), in combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant HIV-1 infection.
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The FDA has approved the drug-device combination product, Xenoview (xenon Xe 129 hyperpolarized), a contrast agent indicated for use with magnetic resonance imaging for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. Xenoview has not been evaluated for use with lung perfusion imaging.
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FDA Labeling Changes
The FDA has approved a label update for Rybelsus (semaglutide) tablets 7mg or 14mg, allowing use as a first-line treatment option for adults with type 2 diabetes who have not previously taken a diabetes treatment. This update removes a previous limitation of use that stated the medication should not be used as the initial therapy for treating patients with type 2 diabetes.
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FDA New Indications
The FDA has approved Actemra (tocilizumab) intravenous for the treatment of COVID-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute IV infusion.
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The FDA has approved an expanded indication for the use of Cytalux (pafolacianine) in lung cancer. Cytalux is the first and only targeted molecular imaging agent that illuminates lung and ovarian cancer intraoperatively, enabling the detection of more cancer for removal. The new indication will provide surgeons the ability to integrate Cytalux into their treatment plan for adult patients with known or suspected lung cancer, where it previously was only approved for adults with ovarian cancer.
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The FDA has approved Ibrance (palbociclib) to include pre-/perimenopausal women in the indication for the treatment of patients with HR-positive, HER2-negative advanced or metastatic breast cancer treated with palbociclib in combination with an aromatase inhibitor as initial endocrine-based therapy.
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The FDA has approved an additional indication for Pemfexy (pemetrexed) injection in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. This represents the fifth indication for Pemfexy.
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The FDA has approved a new indication for Tecentriq (atezolizumab), as a single agent for the treatment of adult and pediatric patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma.
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The FDA has approved Tymlos (abaloparatide), a parathyroid hormone-related peptide analog, as a treatment to increase bone density in men with osteoporosis at high risk of fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or in patients who have failed or are intolerant to other available osteoporosis therapy.
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The FDA has approved Vraylar (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults. This approval marks the fourth indication for Vraylar.
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The FDA has approved a new indication for Wegovy (semaglutide) injection 2.4mg, making it the first-and-only prescription anti-obesity medicine for teens with once-weekly dosing. Wegovy is now also indicated for use in adolescents (≥12 years old) with an initial BMI at or above the 95th percentile for age and sex (based on CDC growth charts) along with a reduced calorie meal plan and increased physical activity.
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The FDA has approved updated drug labeling, including new indications and dosing regimens, for Xeloda (capecitabine) under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for certain older oncology drugs. The recommended capecitabine dose depends on the indication.
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Accord Daptomycin for Injection
Accord Healthcare, Inc. is voluntarily recalling a single lot of daptomycin for injection 500mg/vial, and daptomycin for injection 350mg/vial product contained in cartons imprinted with lot # R2200232 Exp: 01/2025, to the consumer/user level. This product is being recalled because Accord received a product complaint report from a hospital pharmacy that vials labeled as “Daptomycin for Injection 500 mg/vial” were found in cartons labeled as “Daptomycin for Injection 350 mg/vial”. The lot and expiration date printed on the outer carton and inner vial are the same and correspond to “Daptomycin for Injection 500 mg/vial.” Accordingly, Accord is voluntarily recalling all of lot #R2200232, daptomycin for injection 500mg/vial, which may be in outer cartons that read “Daptomycin for Injection 500 mg/vial” OR “Daptomycin for Injection 350 mg/vial.”
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GFA Production After Burn Cream and First Aid Kit
GFA Production is voluntarily recalling one lot of Easy Care first aid AfterBurn Cream, 0.9g single-use packets. The single-use packets are sold in boxes of 10 or packaged in certain first aid kits. This recall is to the consumer level. FDA analysis found the product to be contaminated with Bacillus licheniformis and Bacillus sonorensis.
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Hospira Vancomycin Injection
Hospira is voluntarily recalling one lot of vancomycin hydrochloride injection, USP, 1.5g/vial single dose flip top vial, lot 33045BA, to the user level due to two visible glass particulates observed in a single vial.
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Lupin Pharmaceuticals Inc. is voluntarily recalling four lots of quinapril tablets to the consumer level due to the presence of a nitrosamine impurity, N-nitroso-quinapril, observed in recent testing above the acceptable daily intake level.
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Spectrum Laboratory Products is voluntarily recalling three lots of epinephrine (L-adrenaline) USP, a bulk active pharmaceutical ingredient used to manufacture or compound prescription products, to the user level. Customer complaints have found the product to be discolored.
Learn more about the Spectrum epinephrine recall