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  • FDA Drug Updates

    FDA New Approvals

    Hyftor

    The FDA has approved Hyftor (sirolimus) 0.2% topical gel as the first topical treatment indicated for facial angiofibroma associated with tuberous sclerosis complex in adults and children aged 6 years or older. Learn more about Hyftor

    Opdualag

    The FDA has approved Opdualag (nivolumab/relatlimab-rmbw), a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion for the treatment of adult and pediatric patients aged 12 years or older with unresectable or metastatic melanoma. Learn more about Opdualag

    Pluvicto

    The FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer that has spread to other parts of the body. The FDA also approved the complementary diagnostic imaging agent, Locametz (gallium Ga 68 gozetotide), after radiolabeling with gallium-68 for the identification of prostate-specific membrane antigen–positive lesions. Learn more about Pluvicto

    Tlando

    The FDA has approved Tlando (testosterone undecanoate), an oral treatment for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. Learn more about Tlando

    Triumeq and Triumeq PD

    The FDA has approved Triumeq PD (abacavir/dolutegravir/lamivudine) tablets, dispersible formulation of the fixed-dose combination for the treatment of pediatric patients weighing 10kg to <25kg with human immunodeficiency virus type 1. In addition, a supplemental new drug application has been approved for Triumeq tablet, lowering the minimum weight that a child with human immunodeficiency virus type 1 can be prescribed this medicine to 25kg from 40kg. Learn more about Triumeq and Triumeq PD

    Vijoice

    The FDA has approved Vijoice (alpelisib) for the treatment of adult and pediatric patients aged 2 years and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy. Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies. Learn more about Vijoice

    Xelstrym

    The FDA has approved Xelstrym (dextroamphetamine) transdermal system, CII, for the treatment of attention-deficit/hyperactivity disorder for adults and pediatric patients aged 6 years and older. Xelstrym is the first and only FDA-approved transdermal amphetamine patch. Learn more about Xelstrym

    Ztalmy

    The FDA has approved Ztalmy (ganaxolone) oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD), a rare form of genetic epilepsy, in patients aged 2 years and older. Ztalmy, the first FDA-approved treatment specifically in CDD, is a neuroactive steroid that acts as a positive allosteric modulator of the GABAA receptor. Learn more about Ztalmy

    FDA Labeling Changes

    Cabenuva

    The FDA has approved a label update for Cabenuva (cabotegravir/rilpivirine) making the oral lead-in with cabotegravir and rilpivirine tablets optional. Oral cabotegravir and rilpivirine can be taken for a month to assess tolerability to the medicines prior to initiating cabotegravir and rilpivirine injections. Learn more about Cabenuva

    FDA New Dose Strengths

    Ozempic

    The FDA has approved a 2mg dose of Ozempic (semaglutide), once-weekly subcutaneous injection, a glucagon-like peptide-1 analogue for the treatment of adults with type 2 diabetes. Ozempic is now approved in the US at 0.5mg, 1mg, and 2mg doses for the treatment of type 2 diabetes in adults. Further, Ozempic is indicated to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease. Learn more about Ozempic

    FDA New Indications

    Cabenuva

    The FDA has approved Cabenuva (cabotegravir/rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter) who are aged 12 years or older, weigh at least 35kg, and are on a stable antiretroviral regimen, with no history of treatment failure, nor known or suspected resistance to either cabotegravir or rilpivirine. Learn more about Cabenuva

    Fintepla

    The FDA has approved Fintepla (fenfluramine) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome in patients aged two years and older. It is already approved for the treatment of seizures associated with Dravet syndrome in patients aged two years and older. Additionally, the FDA granted Fintepla pediatric exclusivity. Learn more about Fintepla

    Keytruda

    The FDA has approved Keytruda (pembrolizumab) as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Learn more about Keytruda

    Rinvoq

    The FDA has approved Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. This FDA approval is the first indication for Rinvoq in gastroenterology. Learn more about Rinvoq

    Smoflipid

    The FDA has approved an expanded indication for Smoflipid (lipid injectable emulsion) for intravenous use for pediatric patients, including term and preterm neonates, making it the first and only four-oil lipid emulsion for parenteral nutrition patients of every age. Learn more about Smoflipid

    Yescarta

    The FDA has approved Yescarta (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Learn more about Yescarta

    FDA Recalls

    Adamis Pharmaceuticals Corporation Symjepi

    Adamis Pharmaceuticals Corporation is voluntarily recalling certain lots of Symjepi (epinephrine) injection 0.15mg (0.15mg/0.3mL) and 0.3mg (0.3mg/0.3mL) pre-filled single-dose syringes, to the consumer level. The batches are being recalled due to the potential clogging of the needle preventing the dispensing of epinephrine. Learn more about the Adamis Pharmaceuticals Corporation Symjepi recall

    Best Brands Consumer Products, Inc. Hand Sanitizers

    Best Brands Consumer Products, Inc. is voluntarily recalling two finished product lots of The Mandalorian hand sanitizer ethyl alcohol 68%, available in green and blue formulations, and Mickey Mouse hand sanitizer ethyl alcohol 68%, blue formulation, to the consumer level. FDA testing found the presence of benzene in The Mandalorian hand sanitizer product and methanol in the Mickey Mouse hand sanitizer product. Learn more about the Best Brands Consumer Products, Inc. hand sanitizers recall

    F&S Medical Supply Pink Pussycat Capsules

    F&S Medical Supply, dba Pink Toyz, is voluntarily recalling one lot of Pink Pussycat 3000mg capsules, to the consumer level. FDA analysis has found the product Pink Pussycat to be tainted with sildenafil. Learn more about the F&S Medical Supply Pink Pussycat capsules recall

    Mylan Pharmaceuticals Insulin Glargine

    Mylan Pharmaceuticals Inc. is voluntarily recalling one batch of its insulin glargine (insulin glargine- yfgn) injection, 100 units/mL (U-100), which is packaged in a 10mL vial that is inside a carton. This product is not the branded Semglee vial but the unbranded insulin glargine- yfgn vial. This batch is being recalled due to the potential for the label to be missing on some vials. Learn more about the Mylan Pharmaceuticals insulin glargine recall

    Pfizer Accuretic and Generics

    Pfizer is voluntarily recalling Accuretic (quinapril HCl/HCTZ) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and HCTZ and quinapril HCl/HCTZ) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the acceptable daily intake level. Pfizer will recall six lots of Accuretic tablets, one lot of quinapril and HCTZ tablets and four lots of quinapril HCl/ HCTZ tablets. Learn more about the Pfizer Accuretic and generics recall

    Plastikon Healthcare Products

    Plastikon Healthcare is voluntarily recalling three lots of milk of magnesia 2400mg/30mL oral suspension, one lot of acetaminophen 650mg/20.3mL, and six lots of magnesium hydroxide 1200mg/aluminum hydroxide 1200mg/simethicone 120mg per 30mL, to the hospital, clinic, and patient level. The products are being recalled due to microbial contamination and failure to properly investigate failed microbial testing. Learn more about the Plastikon Healthcare products recall

    Sandoz Orphenadrine Citrate

    Sandoz is initiating a voluntary recall of 13 lots of oral orphenadrine citrate 100mg extended-release tablets, to the consumer level. The presence of a nitrosamine impurity, which has the potential to be above the FDA’s acceptable daily intake limit of 26.5ng/day, was detected in the lots during recent testing. Learn more about the Sandoz orphenadrine citrate recall

    Teva Pharmaceuticals Idarubicin HCl Injection

    Teva Pharmaceuticals has initiated a voluntary nationwide recall of lot 31329657B of idarubicin HCl injection USP 5mg/5mL vial, to the user level in the US. This voluntary recall is initiated based on an internal inspection that found particulate matter in one vial of the product identified as silica and iron oxide. Learn more about the Teva Pharmaceuticals idarubicin HCl injection recall

    Unilever Antiperspirants

    Unilever United States is voluntarily recalling two Suave 24-Hour Protection Aerosol Antiperspirants, to the consumer level. An internal review showed slightly elevated levels of benzene in some product samples. While benzene is not an ingredient in any of the recalled products, the review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can. Learn more about the Unilever antiperspirants recall

    FDA Alerts

    Iodine-containing Contrast Agents

    The FDA is recommending that newborns and children through 3 years old have follow-up thyroid monitoring within 3 weeks after receiving injections of contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures. Review showed that underactive thyroid or a temporary decrease in thyroid hormone levels were uncommon. However, the conditions should be identified and treated early when needed to prevent potential future complications. Newborns, particularly those born premature, and children in their first 3 years with underlying conditions such as heart issues may be at higher risk for problems of the thyroid, a gland in the neck that releases hormones that help control many of the body’s functions. Learn more about iodine-containing contrast agents

    North American Custom Laboratories Sterility Assurance Issue

    The FDA is warning patients and healthcare professionals not to use products intended to be sterile produced by North American Custom Laboratories LLC, DBA FarmaKeio Superior Custom Compounding, due to a lack of sterility assurance. Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening adverse health consequences including infections and sepsis. Learn more about the North American Custom Laboratories sterility assurance issue