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The FDA has approved the bone-building drug PF708 (teriparatide) to treat osteoporosis in certain patients at high risk for fracture. The manufacturer is seeking the FDA’s authorization to designate PF708 as therapeutically equivalent to Forteo. This would permit PF708 to be automatically substituted for Forteo, which lost its market exclusivity in much of the US in August.
Learn more about PF708
The FDA has approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis in patients aged 16 years older. This condition is a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells.
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The FDA has approved Amzeeq (minocycline) 4% topical foam to treat inflammatory lesions of nonnodular moderate to severe acne vulgaris in adults and children aged 9 years or older. It is the first topical minocycline formulation approved by the FDA.
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The FDA has approved the first ready-to-use formulation of phenylephrine HCl injection, Biorphen, for treatment of clinically important hypotension resulting primarily from anesthesia-associated vasodilation. Previously, phenylephrine HCl injection was only available in a highly concentrated formulation that required manual dilution before use or as ready-to-use formulations that needed to be obtained from compounding pharmacies.
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Brukinsa (zanubrutinib) has received accelerated approval from the FDA as a treatment for mantle cell lymphoma in adult patients who have received at least one prior therapy. Brukinsa is a small molecule inhibitor of Bruton's tyrosine kinase.
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The FDA has approved ExEm Foam (air polymer-type A) intrauterine foam as an ultrasound contrast agent indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility.
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The FDA has approved a self-administered version of Fasenra (benralizumab) that comes in a prefilled, single-use autoinjector called Fasenra Pen. Fasenra is an anti-eosinophil humanized monoclonal antibody that selectively targets the interleukin-5 receptor expressed on the surface of eosinophils. Since 2017, Fasenra has been available in the US in a fixed-dose prefilled syringe for subcutaneous administration in a physician's office as add-on maintenance treatment for adults and for children aged 12 years or older who have severe eosinophilic asthma.
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The FDA has approved Fetroja (cefiderocol) for patients aged 18 years or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections, including pyelonephritis, caused by susceptible Gram-negative microorganisms.
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The FDA approved fluorodopa F 18 for the visual detection of certain nerve cells in adult patients with suspected parkinsonian syndromes (PS). Fluorodopa F 18 is injected intravenously in preparation for a PET scan to help detect the damaged or lost dopaminergic nerve cells. It is to be used in addition to other tests for diagnosing PS.
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The FDA approved Quzyttir (cetirizine HCl) for intravenous injection for treatment of acute urticaria in adults and children aged 6 months or older. Quzyttir will be available as 10mg/mL single-use vials. Quzyttir is the first FDA-approved intravenous formulation of cetirizine.
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The FDA has approved Reblozyl (luspatercept-aamt) for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. Reblozyl is the first and only FDA-approved erythroid maturation agent, representing a new class of therapy which works by regulating late-stage red blood cell maturation to help patients reduce their RBC transfusion burden.
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The FDA approved Reyvow (lasmiditan) tablets for the acute treatment of migraine with or without aura in adults. Reyvow is not indicated for the preventive treatment of migraine.
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The FDA approved Secuado (asenapine), an atypical antipsychotic in the form of a transdermal patch for the treatment of adults with schizophrenia. Secuado is applied once daily and provides sustained concentrations of asenapine over 24 hours.
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The FDA has approved Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10mg/250mg/12.5mg for the treatment of Helicobacter pylori infection in adults. Talicia is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to current clarithromycin-based standard-of-care therapies.
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The FDA approved Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. Trikafta is approved for patients aged 12 years and older with cystic fibrosis who have at least one F508del mutation in the CFTR gene, which is estimated to represent 90% of the cystic fibrosis population.
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The FDA has approved Vumerity (diroximel fumarate), a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. Once in the body, Vumerity rapidly converts to monomethyl fumarate, the same active metabolite of dimethyl fumarate.
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The FDA has approved the biosimilar Ziextenzo (pegfilgrastim-bmez). Ziextenzo is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
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The FDA has approved Baxdela (delafloxacin) for the treatment of adults with community-acquired bacterial pneumonia caused by designated susceptible bacteria. This is the second indication for the fluoroquinolone antibiotic.
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The FDA has approved Botox (onabotulinumtoxinA) for the treatment of pediatric patients (aged 2 to 17 years) with lower limb spasticity, excluding spasticity caused by cerebral palsy. This is the eleventh therapeutic indication for Botox.
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The type 2 diabetes medication Farxiga (dapagliflozin) been approved by the FDA for reducing hospitalization for heart failure (HF) in adults with type 2 diabetes and other cardiovascular risk factors. Approval is specific to hospitalization for HF and, as such, represents the first of the class of sodium-glucose cotransporter 2 inhibitors to be approved for this particular indication.
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The FDA has expanded the indication for the more rapid-acting version of insulin aspart, Fiasp, for use in insulin pumps. In Fiasp, niacinamide (vitamin B3) has been added to aspart to help increase the speed of the initial insulin absorption. For mealtime use, it is indicated to be dosed at the beginning of a meal or within 20 minutes after starting a meal, and appears in the blood approximately 2.5 minutes after dosing.
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The FDA has approved an updated indication that increases the duration of use of Liletta (levonorgestrel-releasing intrauterine system) 52mg for the prevention of pregnancy for up to 6 years.
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The FDA has approved Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). Since receiving approval in September 2009 for adults with moderate to severe plaque psoriasis, Stelara has received four additional indications: adolescents with moderate to severe plaque psoriasis; adults with active psoriatic arthritis; adults with moderately to severely active Crohn’s disease; and now adults with moderately to severely active UC.
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The FDA has approved Ultomiris (ravulizumab) to inhibit complement-mediated thrombotic microangiopathy in adults and children aged 1 month or older with atypical hemolytic uremic syndrome. This is the first pediatric approval for the long-acting C5 complement inhibitor. In 2018, the FDA approved ravulizumab for adults with paroxysmal nocturnal hemoglobinuria, another rare blood disorder.
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The FDA has approved a new indication for the oral anticoagulant Xarelto (rivaroxaban) for the prevention of venous thromboembolism in hospitalized acutely ill medical patients at risk for thromboembolic complications, but who are not at high risk of bleeding. Xarelto can now be initiated for these patients during hospitalization and continued after discharge for a total recommended duration of 31 to 39 days.
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The FDA has expanded the indication for Xofluza (baloxavir marboxil) tablets to include people at high risk of developing influenza-related complications. The CDC defines people at high risk of serious flu complications as those who have conditions such as asthma, chronic lung disease, diabetes, heart disease, or morbid obesity, or adults who are aged 65 or older.
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There is now approval for an expanded indication for Zejula (niraparib), an oral, once-daily poly polymerase inhibitor for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients, who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency positive status defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability and who have progressed more than 6 months after response to the last platinum-based chemotherapy. Patient selection is based on an FDA-approved companion diagnostic for Zejula.
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GL Holdings is voluntarily recalling six lots of Green Lumber 2-, 4-, and 10-capsule packages purchased on or before August 10, 2019, to the consumer level. FDA analysis has found one lot of Green Lumber distributed between June and August 2019 to be tainted with tadalafil.
Learn more about the GL Holdings Green Lumber capsules recall
ICU Medical is voluntarily recalling one single lot of lactated ringer's injection, USP (lot # 84-603-FW), and one single lot of 0.9% sodium chloride injection, USP (lot # 95-101-C6). The products are being recalled to the hospital level due to the presence of particulate matter.
Learn more about the ICU Medical lactated ringer's injection recall
Innoveix Pharmaceuticals is voluntarily recalling all sterile compounded drug products, within expiry, to the consumer level. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by the FDA.
Learn more about the Innoveix Pharmaceuticals sterile compounded drug products recall
Med Man Distribution is voluntarily recalling all lots of Up2. FDA laboratory analysis has found Up2 to be tainted with sildenafil. Sildenafil is an FDA-approved prescription drug for erectile dysfunction and the presence of sildenafil in Up2 products make them unapproved drugs for which safety and efficacy have not been established, therefore subject to recall.
Learn more about the Med Man Distribution Up2 recall
Mylan Pharmaceuticals is conducting a voluntary nationwide recall of one lot (8082708) of alprazolam tablets, USP C-IV 0.5mg, to the consumer/user level. This lot is being recalled due to the potential presence of a foreign substance. Clinical impact from the foreign material, if present, is expected to be rare, but the remote risk of infection to a patient cannot be ruled out.
Learn more about the Mylan Pharmaceuticals alprazolam tablets recall
Nature's Rx is voluntarily recalling lot: 01251ZX1, Expiry Date: 11/2022 of Silver Bullet (10 male enhancement capsules). This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor. The undeclared PDE-5 inhibitor in the product may pose serious health risks to consumers with underlying medical issues.
Learn more about the Nature's Rx Silver Bullet recall
Viatrexx Bio is voluntarily recalling 10mL sterile injectable vials of products to the consumer level. The products were sold exclusively to practitioners for office use. The products were manufactured in a manner that cannot guarantee its sterility.
Learn more about the Viatrexx Bio sterile injectable vials recall
The FDA has updated its 2017 safety communication as a reminder that biotin, often found in dietary supplements, can significantly interfere with certain lab tests and cause falsely high or falsely low results, depending on the type of test. The FDA is particularly concerned about biotin interference causing a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, which may lead to a missed diagnosis and potentially serious clinical implications. Some lab test developers have been successful at mitigating the biotin interference of their assays, but others have not yet addressed it.
Learn more about the Biotin safety communication
The FDA advises consumers not to use Rompe Pecho EX and Rompe Pecho CF cough syrups distributed by Efficient Laboratories, due to microbial contamination risks. These are OTC medicines for children aged 6 years and older. The FDA recommends consumers stop using these medicines and dispose of them. These contaminated cough medicines could potentially cause illness.
Learn more about Efficient Laboratories Rompe Pecho cough syrup
CSL Behring is alerting customers to a misalignment in the printing of the data on the folding box of Humate-P (antihemophilic factor/von Willebrand factor complex [human]) that might lead to confusion of the user. On the folding box of Humate-P, the data for von Willebrand factor ristocetin cofactor and factor VIII potency, as well as expiry date and lot number are imprinted next to the preprinted text fields stating “VWF:RCo,” “FVIII,” “EXP,” and “LOT.” Due to an error during packaging, the potency data was shifted downwards. Although positioned incorrectly, the printed potency values on the folding box are correct. Due to the incorrect positioning, the actual von Willebrand factor (VWF:RCo) data could be mistaken as FVIII potency (FVIII) data.
Learn more about the Humate-P alert
The FDA is strengthening its warning to consumers to stop using vaping products containing tetrahydrocannabinol (THC) amid more than 1,000 reports of lung injuries—including some resulting in deaths—following the use of vaping products.
Learn more about the FDA warning the public to stop using vaping products
In September 2019, the FDA issued a public statement alerting that some ranitidine medicines, including Zantac OTC, could contain NDMA at low levels and asked manufacturers to conduct testing. The FDA is continuing to alert professionals and patients to voluntary recalls of ranitidine. Additionally, the agency has issued a statement regarding new testing results.
Learn more about ranitidine product recalls and updates