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  • FDA Drug Updates

    FDA New Approvals

    Adbry

    The FDA has approved Adbry (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis in adults aged 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Learn more about Adbry

    Apretude

    The FDA has approved Apretude (cabotegravir) extended-release injectable suspension as the first and only long-acting injectable pre-exposure prophylaxis option to reduce the risk of sexually acquired HIV-1. The long-acting injectable was approved for use in adults and adolescents weighing at least 35kg who are at risk of sexually acquiring HIV and who have a negative HIV-1 test prior to initiation. Learn more about Apretude

    Cibinqo

    The FDA has approved Cibinqo (abrocitinib), an oral, once-daily, JAK1 inhibitor, for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Learn more about Cibinqo

    Dartisla ODT

    The FDA has approved Dartisla ODT (glycopyrrolate) orally disintegrating tablets for adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Learn more about Dartisla ODT

    Entadfi

    The FDA has approved Entadfi (finasteride/tadalafil) for the treatment of urinary tract symptoms caused by an enlarged prostate called benign prostatic hyperplasia. Learn more about Entadfi

    Leqvio

    The FDA has approved Leqvio (inclisiran), the first and only small interfering RNA therapy to lower low-density lipoprotein cholesterol with two doses a year, after an initial dose and one at three months. Learn more about Leqvio

    Quviviq

    The FDA has approved Quviviq (daridorexant) 25mg and 50mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Learn more about Quviviq

    Recorlev

    The FDA has approved Recorlev (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome for whom surgery is not an option or has not been curative. Learn more about Recorlev

    Rezvoglar

    The FDA has approved Rezvoglar (insulin glargine-aglr) injection for subcutaneous use, a long-acting human insulin analogue indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Learn more about Rezvoglar

    Ryaltris

    The FDA has approved Ryaltris (mometasone furoate monohydrate/olopatadine HCl) fixed-dose, combination drug nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric patients aged 12 years and older. Learn more about Ryaltris

    Tarpeyo

    The FDA has approved Tarpeyo (budesonide) delayed-release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression. Learn more about Tarpeyo

    Tezspire

    The FDA has approved Tezspire (tezepelumab-ekko) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Learn more about Tezspire

    Vyvgart

    The FDA has approved Vyvgart (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody-positive. Learn more about Vyvgart

    Xaciato

    The FDA has approved Xaciato (clindamycin phosphate) vaginal gel, 2% for the treatment of bacterial vaginosis in females aged 12 years and older. Xaciato is a lincosamide antibacterial. Learn more about Xaciato

    Yusimry

    The FDA has approved Yusimry (adalimumab-aqvh) for the treatment of plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis. Learn more about Yusimry

    FDA New Indications

    Caplyta

    The FDA has approved Caplyta (lumateperone) for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate. Learn more about Caplyta

    Cosentyx

    The FDA has approved Cosentyx (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in patients aged 4 years and older, and active psoriatic arthritis (PsA) in patients aged 2 years and older. Cosentyx is now the first biologic indicated for ERA and the only biologic treatment approved for both ERA and PsA in pediatric patients in the US. These are the second and third approvals for Cosentyx in a pediatric population in the US, and Cosentyx now has a total of five indications across rheumatology and dermatology. Learn more about Cosentyx

    Cutaquig

    The FDA has approved Cutaquig (immune globulin, subcutaneous [human]-hipp, 16.5% solution) for the treatment of pediatric patients aged 2 and older with primary humoral immunodeficiency (PI). The FDA previously approved Cutaquig for adults with PI. Learn more about Cutaquig

    Injectafer

    The FDA has approved Injectafer (ferric carboxymaltose) injection for pediatric patients aged 1 year or older with iron deficiency anemia who are intolerant to oral iron or who have had an unsatisfactory response to oral iron. Learn more about Injectafer

    Orencia

    The FDA has approved Orencia (abatacept) for acute graft-versus-host disease prophylaxis, in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients aged 2 years and older undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated donor. This is the fourth indication for Orencia. Learn more about Orencia

    Otezla

    The FDA has approved Otezla (apremilast) for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. With this expanded indication, Otezla is now the first and only oral treatment approved in adult patients with plaque psoriasis across all severities, including mild, moderate, and severe. Learn more about Otezla

    Oxbryta

    The FDA has approved Oxbryta (voxelotor) tablets for the treatment of sickle cell disease (SCD) in children aged 4 to less than 12 years. This approval expands the previously approved use of Oxbryta to treat SCD in patients aged 12 years and older. The FDA also approved a separate New Drug Application for Oxbryta tablets for oral suspension, a new dispersible, once-daily tablet dosage form suitable for patients aged 4 to less than 12 years and older patients who have difficulty swallowing whole tablets. Oxbryta is the first and only approved medicine that directly targets sickle hemoglobin polymerization, the root cause of the sickling and destruction of red blood cells in SCD. Learn more about Oxbryta

    Rinvoq

    The FDA has approved Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children aged 12 years and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended. Learn more about Rinvoq

    Rituxan

    The FDA has approved Rituxan (rituximab) injection, combined with chemotherapy, for treating children aged 6 months to younger than 18 years who have previously untreated, advanced CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia. Learn more about Rituxan

    Siklos

    The FDA has approved a revised indication for Siklos (hydroxyurea) to include the adult patient population to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, aged 2 years and older, with sickle cell anemia with recurrent moderate to severe painful crises. Previously, the treatment was approved only for pediatric patients. Learn more about Siklos

    Vocabria

    The FDA has approved an expanded indication for Vocabria (cabotegravir) tablet to include use as an oral lead-in for Apretude (cabotegravir) extended-release injectable suspension for HIV-1 pre-exposure prophylaxis (PrEP) for adults and pediatric patients aged 12 to less than 18 years weighing at least 35kg and as short-term, oral therapy for HIV-1 PrEP for patients who will miss a planned injection dosing of Apretude. Learn more about Vocabria

    Xarelto

    The FDA has approved Xarelto (rivaroxaban) for the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients from birth to less than age 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment, and for thromboprophylaxis in children aged two years and older with congenital heart disease who have undergone the Fontan procedure. Xarelto now has 11 indications in the US. Learn more about Xarelto

    Xeljanz

    The FDA has approved Xeljanz/Xeljanz XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. This is the fifth indication for Xeljanz. Learn more about Xeljanz

    Zynrelef

    The FDA has approved a supplemental New Drug Application for Zynrelef (bupivacaine/meloxicam) extended-release solution to significantly expand the indication. Zynrelef is now indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. Learn more about Zynrelef

    FDA Recalls

    Edge Pharma Products

    Edge Pharma, LLC is voluntarily recalling all lots of all drugs compounded at Edge Pharma, LLC, to the consumer level. All products are being recalled due to process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products. Learn more about the Edge Pharma recall

    Efficient Laboratories Liquid Cold and Flu Symptom Relief

    Efficient Laboratories is expanding its voluntary nationwide recall to consumers to include an additional twelve lots of Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX, and Rompe Pecho DM due to microbial contamination concerns. These lots were distributed in 2019. Learn more about the Efficient Laboratories recall

    Gilead Veklury

    Gilead Sciences announced it is voluntarily recalling two lots of Veklury (remdesivir) 100mg for injection, to the user level. Gilead Sciences received a customer complaint, confirmed by the firm's investigation, of the presence of glass particulates. Learn more about the Gilead Sciences recall

    Lohxa Senna Syrup

    Lohxa is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL unit-dose cups to the consumer level. The product is being recalled due to microbial contamination. Learn more about the Lohxa Senna Syrup recall

    Mylan Pharmaceuticals Semglee

    Mylan Pharmaceuticals Inc. is voluntarily recalling one batch of its non-interchangeable Semglee (insulin glargine injection), 100 units/mL, 3mL prefilled pens, which are packaged in a labelled carton of five pens. The product is being recalled due to the potential for the label to be missing on some prefilled pens within a labelled carton for this particular batch. Learn more about the Mylan Pharmaceuticals Semglee recall

    Padagis Perrigo Nitroglycerin Lingual Spray

    Padagis announced it issued a voluntary nationwide recall to the consumer/user level of multiple lots of nitroglycerin lingual spray. Out of an abundance of caution, this product is being recalled from the market due to a complaint received that a unit may not dispense. Learn more about the Padagis recall

    Taro Clobetasol Propionate

    Taro is voluntarily recalling one lot of clobetasol propionate ointment USP, 0.05% packaged in 60g tubes, to the consumer level. This recall only applies to tubes labeled with "Lot AC13786" and "Exp Dec 2022." No other lots of this product are impacted. Lot AC13786 is being recalled due to the presence of Ralstonia pickettii bacteria, which the manufacturer discovered through routine testing. Learn more about the Taro recall

    Teligent Lidocaine

    Teligent Pharma, Inc. is voluntarily recalling two lots of lidocaine HCl topical solution USP 4%, 50mL in a screw cap glass bottle, to the user level. The product is being recalled because the firm's testing has found it to be super-potent based on an out-of-specification result obtained at the 9-month (Lot 16345) and 18-month (Lot 15594) stability timepoint. Learn more about the Teligent recall

    Viona Metformin HCl

    Viona Pharmaceuticals Inc. is voluntarily recalling 33 lots of metformin HCl extended-release tablets, USP 750mg, to the retail level. The reason for the recall is an out-of-specification result observed for the said product, Lot number M008132, "N-nitrosodimethylamine (NDMA) (By GC-MS/MS)" test at 17 Month(s), 25°C/60%RH Long-term stability samples. As a precautionary measure firm voluntarily recalled all the marketed 33 batches having a valid shelf life. Learn more about the Viona recall

    FDA Alerts

    Dental Problems with Buprenorphine

    The FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues. Learn more about dental problems with buprenorphine