FDA New Approvals
The FDA approved Dengvaxia (CYD-TDV), the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3, and 4) in people aged 9 through 16 years who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in the US territories of American Samoa, Guam, Puerto Rico, and the US Virgin Islands.
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The FDA has approved Duobrii (halobetasol propionate and tazarotene) lotion for treatment of plaque psoriasis in adults. Duobrii is the first and only topical lotion that combines both halobetasol propionate and tazarotene in one formulation.
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The FDA approved Eticovo (etanercept-ykro), a biosimilar to Enbrel (etanercept). Eticovo is a tumor necrosis factor blocker indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis in patients aged 2 years or older, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in patients aged 4 years or older.
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The FDA has approved Qternmet XR (dapagliflozin, saxagliptin, and metformin HCl) extended-release tablets as an oral adjunct treatment to diet and exercise to improve glycemic control in adults with type-2 diabetes. Qternmet XR is a once-daily, oral medicine comprised of the selective sodium‑glucose cotransporter-2 inhibitor dapagliflozin, the dipeptidyl peptidase‑4 inhibitor saxagliptin, and metformin HCl extended release.
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The FDA approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients aged 6 years to less than 17 years. This is the first FDA approval of a treatment specifically for pediatric patients with LEMS. The only other treatment approved for LEMS is only approved for use in adults.
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The FDA approved Skyrizi (risankizumab-rzaa) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The approved recommended dosage of Skyrizi is 150mg (two 75mg injections) administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
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The FDA approved Tibsovo (ivosidenib) for newly-diagnosed acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 mutation, as detected by an FDA-approved test, in patients who are at least aged 75 years or who have comorbidities that preclude the use of intensive induction chemotherapy.
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Vyndaqel and Vyndamax
The FDA approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. Vyndaqel and Vyndamax are two oral formulations of the first-in-class transthyretin stabilizer tafamidis, and the first and only medicines approved by the FDA to treat ATTR-CM.
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FDA New Indications
The FDA approved Benlysta (belimumab) intravenous infusion for treatment of children from as young as age 5 with systemic lupus erythematosus (SLE). This is the first time that the FDA has approved a treatment for pediatric patients with SLE. Benlysta has been approved for use in adult patients since 2011.
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The FDA approved Kadcyla (ado-trastuzumab emtansine) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected based on an FDA-approved companion diagnostic for Kadcyla.
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The FDA approved Keytruda (pembrolizumab) plus Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma.
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The FDA approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children aged 12 to 17 years weighing at least 45kg. Mavyret was previously approved to treat HCV in adults in 2017.
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The FDA has approved Praluent (alirocumab) to reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. The FDA also approved Praluent as an adjunct to diet, alone or in combination with other lipid-lowering therapies (eg, statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce LDL-C.
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Alvogen Fentanyl Transdermal System
Alvogen is voluntarily recalling two lots (180060, 180073) of fentanyl transdermal system 12mcg/h transdermal patches to the consumer level. A small number of cartons labeled 12mcg/h fentanyl transdermal system patches contained 50mcg/h patches. The 50mcg/h patches that were included in cartons labeled 12mcg/h are individually labeled as 50mcg/h.
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AmEx Pharmacy Bevacizumab Injectable
AmEx Pharmacy is voluntarily recalling one lot (190212AB, BUD 5/13/2019) of bevacizumab 1.25mg/0.05mL 31G injectable to the consumer/user level. The monoject syringe of this product may become difficult to express, and when additional force is applied, while the needle is in the eye, may cause injury to the patient. AmEx Pharmacy has received three reports associated with the lot being recalled as either being difficult to express, two of which, resulted in an adverse drug event. The product is used for wet age-related macular degeneration and diabetic retinopathy.
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D.B.P. Distribution Titanium 4000 Capsules
D.B.P. Distribution is voluntarily recalling all lots of Titanium 4000 capsules to the consumer level. FDA analysis has found this product to be tainted with sildenafil and tadalafil. The presence of sildenafil and tadalafil makes Titanium 4000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
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Legacy Pharmaceutical Packaging Losartan Potassium Tablets
Legacy Pharmaceutical Packaging is expanding its consumer-level recall of 3 repackaged lots of losartan tablets USP 50mg to include one additional lot. This recall was prompted due to Torrent Pharmaceuticals issuing a Voluntary Nationwide Recall of losartan tablets, USP, due to the detection of trace amounts of N-nitroso-N-methyl 4-aminobutyric acid. The affected losartan potassium includes four repackaged lot numbers (180190, 180191, 191597, 180598).
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Life Rising Corporation Supplements
Life Rising is recalling Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing tablets because the products have the potential to contain excessive levels of lead. The recall includes all products purchased before May 2, 2019 of the Life Rising Holder-W Holder Warmer capsules and Life Rising NECK-ND Neck Clear capsules and lot number T81171040 of the HoliCare Metabolism Cleansing tablets. The Life Rising Holder-W Holder Warmer capsules are sold in a bottle with 54 capsules, the Life Rising NECK-ND Neck Clear capsules are sold in a bottle with 54 capsules, and the HoliCare Metabolism Cleansing tablets are sold in a bottle with 60 tablets, marked with lot # T81171040 on the bottom.
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Novartis Promacta Suspension
Novartis is voluntarily recalling all of three lots of Promacta (eltrombopag) 12.5mg for oral suspension to the consumer level. The oral suspension lots are being recalled because of a risk of potential peanut flour contamination that occurred at a third-party contract manufacturing site. Promacta tablets in 12.5mg, 25mg, 50mg, and 75mg strengths are not impacted by this recall and are not manufactured in the same facility.
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Par Pharmaceutical Mycophenolate Mofetil for Injection
Par Pharmaceutical is voluntarily recalling one lot (AD812, expiry 09/2020) of mycophenolate mofetil for injection, USP to the hospital and retail pharmacy level. One vial of product was observed containing a glass fragment after reconstitution.
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Sagent Pharmaceuticals Ketorolac Tromethamine Injection
Sagent Pharmaceuticals announced the voluntary nationwide recall of one lot (M813513) of ketorolac tromethamine injection, USP, 60mg/2mL (30mg per mL). Sagent has initiated this voluntary recall to the user level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
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Stiff Boy The Beast Capsules
Stiff Boy is voluntarily recalling all lots within expiry of The Beast capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil.
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Teva Losartan Potassium Tablets
Teva has initiated a voluntary recall in the US, to the patient level, of 35 lots of bulk losartan potassium USP tablets (6 lots of 25mg strength and 29 lots of 100mg strength). This recall is due to the detection of an impurity, N-nitroso-N-methyl-4-aminobutyric acid, found in six lots losartan potassium tablets of active pharmaceutical ingredient manufactured by Hetero Labs Limited that is above the FDA’s interim acceptable exposure limit.
Learn more about the Teva losartan potassium tablets recall
Torrent Pharmaceuticals Losartan Potassium and Losartan Potassium/HCTZ Tablets
Torrent Pharmaceuticals is expanding its recall for losartan potassium tablets USP and losartan potassium/HCTZ tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The recall is expanded to include an additional 36 lots of losartan potassium tablets USP and 68 lots of losartan potassium/HCTZ tablets, USP. The impurity detected in the API is N-nitroso-N-methyl-4-aminobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain NMBA above the acceptable daily intake levels released by the FDA.
Learn more about the Torrent Pharmaceuticals losartan potassium and losartan potassium/HCTZ tablets recall
Vivimed Life Sciences Losartan Potassium Tablets
Vivimed Life Sciences is recalling 19 lots of losartan potassium tablets USP 25mg, 50mg, and 100mg to the consumer level. Due to the detection of an impurity, N-nitroso-N-methyl-4-aminobutyric acid, that is above the FDA’s interim acceptable exposure limit.
Learn more about the Vivimed Life Sciences losartan potassium tablets recall
New Boxed Warning: Certain Prescription Insomnia Medicines
The FDA is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with the following insomnia medications versus other prescription medicines used for sleep: Lunesta (eszopiclone), Sonata (zaleplon), and Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist (zolpidem).
Learn more about new boxed warning on certain prescription insomnia medicines