The FDA has approved Aponvie (aprepitant) injectable emulsion, for intravenous use for the prevention of postoperative nausea and vomiting (PONV) in adults. Aponvie is the first and only IV formulation of aprepitant for PONV prevention.
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The FDA has approved Elucirem (gadopiclenol) injection. This next-generation, highly stable macrocyclic gadolinium-based contrast agent has the highest relaxivity in its class for magnetic resonance imaging and is indicated for use in adults and children aged 2 years and older.
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The FDA has approved Iheezo (chloroprocaine HCl) ophthalmic gel 3% for ocular surface anesthesia. Iheezo is a sterile, single-patient-use, physician-administered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia. Iheezo represents the first approved use in the US ophthalmic market of chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the US ophthalmic market in nearly 14 years.
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The FDA has approved Lytgobi (futibatinib) tablets for the treatment of adult patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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The FDA has approved Omlonti (omidenepag) isopropyl ophthalmic solution 0.002% eye drops for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.
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The FDA has approved Pedmark (sodium thiosulfate) injection to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged one month and older with localized, non-metastatic solid tumors. This approval makes Pedmark the first and only treatment approved by the FDA in this area of significant unmet medical need.
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The FDA has approved Relyvrio (sodium phenylbutyrate/taurursodiol) for the treatment of adults with amyotrophic lateral sclerosis (ALS). Relyvrio significantly slowed the loss of physical function in people living with ALS in a randomized, placebo-controlled clinical trial.
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The FDA has approved Rolvedon (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
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The FDA has approved Skysona (elivaldogene autotemcel), also known as eli-cel, to slow the progression of neurologic dysfunction in boys aged 4-17 years with early, active cerebral adrenoleukodystrophy.
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The FDA has approved Terlivaz (terlipressin) for injection. Terlivaz is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.
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The FDA has approved Vegzelma (bevacizumab-adcd), a biosimilar referencing Avastin. Vegzelma is a vascular endothelial growth factor inhibitor indicated for the treatment of metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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The FDA has approved Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis. With this approval, Dupixent becomes the first and only medicine specifically indicated to treat prurigo nodularis in the US. This approval marks the fifth indication for Dupixent.
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The FDA has approved an additional indication for ophthalmic vascular endothelial growth factor inhibitor Eylea (aflibercept) intravitreal injection for retinopathy of prematurity.
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The FDA has approved the supplemental New Drug Application to expand the indicated age range for Firdapse (amifampridine) tablets 10mg to include pediatric patients aged 6 years and older for the treatment of Lambert-Eaton myasthenic syndrome.
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The FDA has approved Retevmo (selpercatinib) 40mg and 80mg capsules for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. In addition to the tumor-agnostic approval, the FDA has granted traditional approval for Retevmo in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion, as detected by an FDA-approved test. This FDA action broadens the Retevmo label to include patients with locally advanced disease and converts the May 2020 accelerated approval for NSCLC to a traditional approval.
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The FDA has approved Trogarzo (ibalizumab-uiyk) for administration by intravenous (IV) push, a method by which the undiluted medication is “pushed” by syringe for faster administration into the body’s circulation. Trogarzo, in combination with other antiretrovirals (ARVs), is indicated for the treatment of human immunodeficiency virus type 1 infection in heavily treatment-experienced adults with multidrug-resistant virus failing their current ARV regimen. The FDA originally approved Trogarzo, a novel, long-acting monoclonal antibody, in March 2018 to be administered intravenously as a single loading dose followed by a 15-minute maintenance dose every two weeks. Following this new approval, the maintenance dose can be administered as an undiluted IV push over 30 seconds.
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Eugia Auromedics Acyclovir Sodium Injection
Eugia has initiated a voluntary recall of lot number AC22006 of Auromedics acyclovir sodium injection 500mg per 10mL (50mg/mL), 10mL single-dose vial to the consumer level from the US market due to a product complaint for the presence of a dark red, brown, and black particulate inside the vial.
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Golden State Medical Supply Atenolol and Clopidogrel
Golden State Medical Supply has initiated a voluntary recall of clopidogrel 75mg tablets and atenolol 25mg tablets because a report was received that a bottle containing clopidogrel 75mg tablets produced with lot# GS046745 was mislabeled as atenolol 25mg tablets. This voluntary recall only affects products with lot# GS046745. No other clopidogrel or atenolol products marketed by Golden State Medical Supply are impacted. Both products are being recalled out of an abundance of caution.
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Proper Trade LLC/My Stellar Lifestyle Wonder Pill
Proper Trade LLC/My Stellar Lifestyle is voluntarily recalling Wonder Pill lot 20210912 and lot 31853-501, expiry 09/24, packaged in 10-count blisters co-packaged in a carton and in 60-count bottles, to the consumer level. Proper Trade LLC/My Stellar Lifestyle was notified by Amazon that laboratory analysis found the product to be tainted with tadalafil. The presence of tadalafil in Wonder Pill capsules makes this product an unapproved drug for which the safety and efficacy have not been established and, therefore, subject to recall.
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