FDA New Approvals
The FDA approved Daurismo (glasdegib) tablets for use in combination with low-dose cytarabine, a type of chemotherapy, for the treatment of newly diagnosed acute myeloid leukemia in adults who are aged 75 years or older or who have other chronic health conditions or comorbidities that may preclude the use of intensive chemotherapy.
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The FDA approved Dextenza (dexamethasone), the first intracanalicular insert that delivers dexamethasone to treat ocular pain following ophthalmic surgery. Dextenza, inserted in the lower lacrimal punctum and canaliculus, releases 0.4mg dexamethasone for up to 30 days following insertion. Dextenza is resorbable and does not need to be removed. Saline irrigation or manual expression can be performed to remove the insert if necessary.
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The FDA approved Firdapse (amifampridine) 10mg tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder that affects the connection between nerves and muscles and causes weakness and other symptoms in affected patients. This is the first FDA approval of a treatment for LEMS.
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The FDA has approved Gamifant (emapalumab-lzsg), an interferon gamma-blocking antibody for the treatment of pediatric (newborn and older) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy.
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The FDA has approved Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Herceptin (trastuzumab).
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The FDA has approved Motegrity (prucalopride), a once-daily, oral treatment option for adults with chronic idiopathic constipation (CIC). Motegrity, a selective serotonin-4 receptor agonist, provides a different class of treatment for CIC that works by enhancing colonic peristalsis to increase bowel motility. Motegrity is expected to launch in 2019 in the US.
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The FDA has approved a new over-the-counter (OTC) version of Primatene Mist (epinephrine) inhalation aerosol bronchodilator suspension for the temporary relief of mild symptoms of intermittent physician-diagnosed asthma in patients aged 12 years and older. Primatene Mist is the only OTC asthma inhaler available in the US.
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The FDA has approved the dual-antiretroviral combination tablet Temixys (lamivudine/tenofovir disoproxil fumarate). The tablet contains tenofovir disoproxil fumarate, which is manufactured as an individual tablet under the brand name Viread and is a nucleoside/nucleotide reverse transcriptase inhibitor (NRTI). The second medication in the tablet is also an NRTI: Epivir (lamivudine).
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The FDA has approved Tolsura (SUBA-itraconazole) 65mg capsules. Tolsura is a new formulation of itraconazole indicated for the treatment of certain systemic fungal infections in adult patients. Tolsura is indicated for the treatment of blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis) and aspergillosis (pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy).
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The FDA approved Truxima (rituximab-abbs), the first biosimilar rituximab for use in non-Hodgkin’s lymphoma (NHL). Rituximab, a monoclonal antibody directed against CD20, is widely used for NHL, both in combination with chemotherapy and on its own.
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The FDA granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific biomarker. This is the second time the agency has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated.
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The FDA approved Xospata (gilteritinib) for the treatment of adult patients who have relapsed or refractory (resistant to treatment) acute myeloid leukemia with an FLT3 mutation as detected by an FDA-approved test. Xospata is an oral therapy and the first and only FLT3-targeting therapy to be approved by the FDA for this population.
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FDA New Indications
The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.
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The FDA has approved Tecentriq (atezolizumab), in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
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The FDA granted accelerated approval to Venclexta (venetoclax) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia in adults who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
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Fresenius Kabi USA Sodium Chloride Injection 0.9% 10mL and 20mL Vials
Fresenius Kabi USA is voluntarily recalling 163 lots of sodium chloride injection, USP, 0.9%, 10mL fill in a 1 mL vial and sodium chloride injection, USP, 0.9%, 20mL fill in a 20mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain natural rubber latex.
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Mylan Pharmaceuticals Valsartan-containing Products
Mylan Pharmaceuticals is expanding its consumer-level voluntary nationwide recall to include all lots of valsartan-containing products within expiry. The 104 additional lots include 26 lots of amlodipine and valsartan tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg, and 10mg/320mg strengths), 51 lots of valsartan tablets, USP (including 40mg, 80mg, 160mg, and 320mg strengths), and 27 lots of valsartan and hydrochlorothiazide tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg strengths). Out of caution, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine, contained in the active pharmaceutical ingredient valsartan, USP, manufactured by Mylan Laboratories Limited.
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Teva Pharmaceuticals Amlodipine/Valsartan and Amlodipine/Valsartan/Hydrochlorothiazide Tablets
Teva Pharmaceuticals has initiated a voluntary recall in the US, to the patient level, of all lots of amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets due to the impurity N-nitrosodiethylamine detected above specification limits in an active pharmaceutical ingredient manufactured by Mylan India.
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Tris Pharma, Inc. Ibuprofen Concentrated Oral Suspension 50mg/1.25mL
Tris Pharma, Inc. has voluntarily recalled three lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50mg per 1.25mL, to the retail level. Included lot numbers are 00717009A, 00717015A, and 00717024A. The recalled lots of the product have been found to have potentially higher concentrations of ibuprofen.
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Gilenya Discontinuation Risk
The FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.
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High Levels of Heavy Metals in Kratom Products
The FDA warns of high levels of heavy metals found in kratom products, including lead and nickel, at levels not considered safe for human consumption. Chronic use could potentially cause heavy metal poisoning.
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Idhifa: Differentiation Syndrome
The FDA reports the life-threatening adverse effect known as differentiation syndrome is not being recognized by clinicians in patients receiving the acute myeloid leukemia drug Idhifa (enasidenib). Early recognition and aggressive management of differentiation syndrome are needed to lessen the likelihood of serious illness and death. The syndrome has occurred as early as 10 days and up to 5 months after starting the medicine.
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Illegally Marketed Tianeptine Products
The FDA has sent warning letters to two companies illegally marketing dietary supplements containing the unapproved antidepressant Stablon (tianeptine) which the companies claim can relieve opioid addiction, pain, and anxiety. The warning letters were sent to Jack B Goods Outlet Store for its Tianaa Red, Tianaa White, and Tianaa Green products and to MA Labs for its Vicaine product.
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Lemtrada: Risk of Stroke and Blood Vessel Wall Tears
The FDA is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis shortly after they received Lemtrada (alemtuzumab). These problems can lead to permanent disability and even death. These risks have been added to the prescribing information and patient medication guide, and the risk of stroke has been added to the existing Boxed Warning.
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Promise Pharmacy Sterile Products
The FDA is alerting healthcare professionals and patients due to lack of sterility assurance not to use drug products intended to be sterile that were produced in an inadequately designed processing room and distributed by Promise Pharmacy.
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Rhino Male Enhancement Products
The FDA is warning consumers not to purchase or use Rhino male enhancement products, due to a recent rise in reported health issues. Since 2007, the FDA has identified more than 25 products marketed with variations of the name “Rhino” that contained hidden drug ingredient(s).
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