FDA New Approvals
The FDA granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the US for the treatment of Chagas disease. Benznidazole was approved using the Accelerated Approval pathway. The FDA granted benznidazole priority review and orphan product designation. These designations were granted because Chagas disease is a rare disease, and until now, there were no approved drugs for Chagas disease in the US.
Learn more about benznidazole
The FDA approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Besponsa is a targeted therapy that is thought to work by binding to B-cell ALL cancer cells that express the CD22 antigen, blocking the growth of cancerous cells.
Learn more about Besponsa
The FDA approved Cyltezo (adalimumab-adbm) for multiple indications. Cyltezo is administered by injection. This is the second FDA-approved biosimilar to Humira (adalimumab).
Learn more about Cyltezo
The FDA has approved Duzallo (lesinurad and allopurinol) for the treatment of hyperuricemia associated with gout in patients for whom target serum uric acid levels have not been achieved with allopurinol alone. Once-daily Duzallo contains lesinurad 200mg plus allopurinol 300mg. Duzallo will also be available in a dose of lesinurad 200mg plus allopurinol 200mg. Duzallo is not recommended for the treatment of asymptomatic hyperuricemia. Duzallo is the first drug that combines the current standard of care for gout-associated hyperuricemia, allopurinol, with the most recent FDA-approved treatment for this condition, lesinurad.
Learn more about Duzallo
The FDA has approved Gocovri (amantadine) extended-release capsules for treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is the first FDA-approved medicine for the treatment of dyskinesia in Parkinson's disease patients. Gocovri is a high-dose 274mg amantadine (equivalent to 340mg amantadine HCl) taken once daily at bedtime that delivers consistently high levels of amantadine from the morning and throughout the day when dyskinesia occurs.
Learn more about Gocovri
The FDA has approved Kedrab [rabies immune globulin (human)], a plasma-derived human rabies immune globulin for passive, transient postexposure prophylaxis of rabies infection. Kedrab should be given immediately after contact with a rabid or possibly rabid animal, concurrently with a full course of rabies vaccine.
Learn more about Kedrab
The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL), the first gene therapy available in the US. Kymriah, a cell-based gene therapy, is approved for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse. Kymriah is a genetically-modified autologous T-cell immunotherapy. Each dose of Kymriah is a customized treatment created using an individual patient’s own T-cells, a type of white blood cell known as a lymphocyte. The patient’s T-cells are collected and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells to target and kill leukemia cells that have a specific antigen (CD19) on the surface. Once the cells are modified, they are infused back into the patient to kill the cancer cells.
Learn more about Kymriah
The FDA granted regular approval to Lynparza (olaparib) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.
Learn more about Lynparza
The FDA approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory).
Learn more about Mylotarg
Senographe Pristina with Self-Compression Mammography System
The FDA granted premarket clearance of the Senographe Pristina with Self-Compression, the first 2D digital mammography system designed to give the patient an active role in the application of compression. The system has a handheld wireless remote control that patients can use to adjust the compression force after breast positioning. The FDA determined that the Senographe Pristina with Self-Compression is substantially equivalent to the predicate device Senographe Pristina.
Learn more about Senographe Pristina with Self-Compression
The FDA approved Vabomere (meropenem and vaborbactam) for treatment of patients 18 years and older with complicated urinary tract infections, including pyelonephritis, caused by specific bacteria. Vabomere is associated with serious risks including allergic reactions and seizures. Vabomere should not be used in patients with a history of anaphylaxis, a type of severe allergic reaction to products in the class of drugs called beta-lactams.
Learn more about Vabomere
FDA Labeling Updates
The FDA approved a safety label change for Ameluz (aminolevulinic acid hydrochloride) that includes a new subsection with the warning and precaution of transient amnestic episodes, which have been reported during postmarketing use of Ameluz in combination with photodynamic therapy. Patients should contact their healthcare provider if amnesia develops after treatment.
Learn more about the Ameluz labeling update
Argatroban in 0.9% Sodium Chloride
The FDA approved a safety labeling change for argatroban in 0.9% sodium chloride that includes an update to the pediatric use section, adding more information regarding pediatric pharmacokinetics and pharmacodynamics.
Learn more about the argatroban in 0.9% sodium chloride labeling update
The FDA approved a safety labeling change for products containing codeine to include the boxed warning of extra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children. Life-threatening respiratory depression and death have occurred in children who received codeine. Some of the reported cases occurred following tonsillectomy and/or adenoidectomy, and at least one case, the child had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. Codeine is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of codeine in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.
Learn more about the codeine labeling update
Ethinyl Estradiol-Containing Products
The FDA approved a safety labeling change for products containing ethinyl estradiol to include the contraindication of using these products in combination with hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir due to the potential for ALT elevations. During clinical trials with the hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as combined oral contraceptives.
Learn more about the ethinyl estradiol labeling update
The FDA approved a safety labeling change for products containing tramadol to include the boxed warning of extra-rapid metabolism of tramadol and other risk factors for life-threatening respiratory depression in children. Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases occurred following tonsillectomy and/or adenoidectomy, and at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism. Tramadol is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of tramadol in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol.
Learn more about the tramadol labeling update
FDA New Indications
The FDA expanded the approval of Actemra/RoActemra (tocilizumab) to treat CAR T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients 2 years of age or older. In clinical trials in patients treated with CAR T cells, 69 percent of patients had complete resolution of CRS within two weeks following one or two doses of Actemra/RoActemra.
Learn more about Actemra/RoActemra
The FDA has approved Austedo (deutetrabenazine) for the treatment of tardive dyskinesia (TD) in adults. Austedo was previously approved for the treatment of chorea associated with Huntington's disease in April 2017. The new approval was based on results from two phase III randomized, double-blind, placebo-controlled, parallel group studies assessing the efficacy and safety of Austedo in reducing the severity of abnormal involuntary movements associated with TD.
Learn more about Austedo
The FDA approved Fycompa (perampanel) for monotherapy use for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. Support for the use of perampanel as monotherapy for the treatment of POS is based on extrapolation of pharmacokinetic (PK) information deemed adequate to demonstrate that the proposed dosages of a drug, when used as monotherapy, should result in exposures that are similar to those demonstrated to be safe and effective when the drug is used as adjunctive therapy for the treatment of POS, taking into consideration possible drug-drug interactions (inhibition or induction) that may alter the metabolism of the drug. This extrapolation relied on population PK analyses (healthy subjects from 19 Phase 1 studies and pooled data from three POS pivotal Phase 3 studies) that were submitted to the FDA with the original NDA for adjunctive therapy of POS.
Learn more about Fycompa
The FDA has approved QVAR RediHaler (beclomethasone dipropionate HFA) inhalation aerosol, a breath-actuated inhaler for the maintenance treatment of asthma in children aged 4 years and older. QVAR RediHaler delivers the medication via a breath-actuated metered-dose inhaler, eliminating the need for hand-breath coordination during inhalation. The product is expected to become commercially available in both 40mcg and 80mcg strengths to patients by prescription during the first quarter of 2018.
Learn more about QVAR RediHaler
The FDA has approved Tracleer (bosentan) for pediatric patients aged 3 years and older with idiopathic or congenital pulmonary arterial hypertension (PAH). This is the first FDA-approved medication for pediatric PAH patients. The drug will be available in a new 32mg tablet that is scored to allow weight-based dose adjustment. It can be dispersed in a teaspoon of water before being given orally. Tracleer is expected to improve exercise ability by improving pulmonary vascular resistance. The 32mg dosage option of Tracleer is expected to be available by the fourth quarter of 2017. The existing 62.5mg and 125mg dosages for adult use will remain available.
Learn more about Tracleer
The FDA has approved
a new indication for Victoza (liraglutide) for reducing the risk of major adverse cardiovascular (CV) events, heart attack, stroke
and CV death, in adults with type 2 diabetes and established CV disease.
This is the second time a drug initially
approved for glucose lowering in type 2 diabetes has gained an additional
indication for CV benefit based on
results from FDA-mandated CV outcomes trials. The new approval for liraglutide is broader, encompassing prevention of CV events
as well as death. The FDA's decision was based
on results from the LEADER
(Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular
Long Term Evaluation) trial, in which liraglutide reduced the risk for the
composite endpoint of CV death, nonfatal myocardial infarction, and nonfatal
stroke by 13% compared with placebo (p=0.01),
with an absolute risk reduction of 1.9%.
Learn more about Victoza
Activase 100mg Vial
Genentech is voluntarily recalling three lots of Activase (alteplase) 100mg vials, that were co-packaged with sterile water for injection, to the hospital level. The vials of sterile water for injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100mg, may be cracked or chipped at the neck of the vial and leaking.
Learn more about the Genentech Activase vial recall
Amneal Pharmaceuticals Lorazepam Oral Concentrate, USP 2mg/mL
Amneal Pharmaceuticals LLC is voluntarily recalling 13 lots of lorazepam oral concentrate, USP 2mg/mL, to the consumer level due to a defect in the dropper markings. The lorazepam oral concentrate, USP 2mg/mL product is packaged with a dosing dropper, supplied to Amneal by a third party. In a few instances, the dropper is printed with the dose markings in reverse number order, has no dose markings, or has dose markings that are shifted. Amneal learned about the issue from a consumer's report.
Learn more about the Amneal Pharmaceuticals lorazepam oral concentrate recall
Bella Pharmaceuticals Sterile Drug Products
Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to healthcare facilities nationwide. Bella Pharmaceuticals has not received any reports of adverse events.
Learn more about the Bella Pharmaceuticals sterile drug products recall
Datascope/MAQUET Intra-Aortic Balloon Pumps
Datascope/MAQUET is recalling its CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps (IABPs) manufactured July 1, 2003 to June 16, 2017 due to False Blood Detection Alarm and Ingress of Fluid into the IABP. If a patient requires circulatory support with an IABP and the device does not work, or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.
Learn more about the Datascope/MAQUET intra-aortic balloon pumps recall
Doctor Manzanilla Products
Mid Valley Pharmaceutical is
recalling lot# 23221701 of Doctor Manzanilla Cough & Cold and lot# 23221701
of Doctor Manzanilla Allergy & Decongestant Relief syrup to the consumer
level. The products may potentially be contaminated with the bacteria Burkholderia cepacia. Contaminated products with B. cepacia can
potentially result in serious infections and may be life-threating in
patients with compromised immune systems. Mid Valley Pharmaceutical has not
received any reports of adverse events related to this recall.
Learn more about the Doctor Manzanilla products recall
Hospira Hydromorphone HCl Injection, USP 2mg/mL, and Levophed 4mg/4mL (1mg/mL) Vial
Hospira is voluntarily recalling one lot of hydromorphone HCI injection, USP, CII 2mg/mL and four lots of Levophed (norepinephrine bitartrate injection, USP), 4mg/4mL (1mg/mL) vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. The possibility of a breach in sterility assurance in distributed product, while not confirmed, cannot be eliminated. No batches of product have been identified as containing microorganisms. Hospira has not received reports of any adverse events associated with this issue for these lots.
Learn more about the Hospira hydromorphone HCl injection and Levophed vial recall
Hospira Vancomycin HCl for Injection, USP, 750mg/vial
Hospira is voluntarily recalling one lot of vancomycin HCl for injection, USP, 750mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial. Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
Learn more about the Hospira vancomycin HCl injection 750mg/vial recall
Medtronic Diabetes Infusion Sets
Medtronic has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. The company determined, through recent field reports from patients and root cause analysis, that a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Currently manufactured infusion sets, available to patients since April 2017, include a design update of this component which the company believes reduces the risk of insulin over-delivery after an infusion set change. The company will work with patients to ensure recalled infusion sets with the discontinued component are returned and replaced with new infusion sets containing the updated component at no cost.
Learn more about the Medtronic diabetes infusion sets recall
Ninjacof and Ninjacof A
Centurion Labs is voluntarily
recalling 1 lot of Ninjacof (Lot# 200N1601) (NDC
23359-032-16) and 1 lot of Ninjacof A
(Lot# 201NA1601) (NDC 23359-033-16) manufactured
by Vilvet and distributed by Centurion Labs to the retail level due to
potential contamination with Burkholderia cepacia.
Ninjacof and Ninjacof A are used to temporarily relieve symptoms due to the
common cold, allergic rhinitis or other respiratory allergies. Centurion was notified by the FDA regarding the
potential contamination as they discovered this product may have been manufactured
in a Pharmatech, FDA-registered facility, in Davie, FL that was found to have a
product that contained B. cepacia. Products
are sold in 473mL bottles with the expiration date of 11/2018.
Learn more about the Centurion Labs Ninjacof and Ninjacof A recall
PharMEDium Unexpired Lots of Oxytocin
PharMEDium is voluntarily recalling all unexpired lots of oxytocin compounded with lactated Ringers and all unexpired lots of oxytocin compounded with lactated Ringers and dextrose products that were produced between July 6, 2017 and August 29, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of oxytocin compounded with lactated Ringers and oxytocin compounded with lactated Ringers and dextrose which would lead to a lower dose being administered. Although oxytocin is titrated based on clinical response, an extreme and unexpected reduction in dose could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of patient's conditions.
Learn more about the PharMEDium oxytocin recall
Piyanping Anti-Itch Lotion
Lucky Mart Inc. is voluntarily recalling lots C14005, C16001 and C16002 of Piyanping Anti-Itch Lotion to the consumer level. The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Dexamethasone is not listed as an ingredient in the labeling. Dexamethasone is a higher potency steroid than hydrocortisone and may have a longer half-life; it could potentially cause serious side effects in patients applying the cream multiple times daily.
Learn more about the Piyanping recall
Zenith Alpha Thoracic Endovascular Graft
Cook Medical initiated a correction to the Instructions for Use for the Zenith Alpha Thoracic Endovascular Graft. This correction removed the indication for blunt thoracic aortic injury, also known as BTAI or “transection” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these grafts specifically in the treatment of BTAI. Cook also initiated a voluntary recall of Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device. These specific sizes are primarily used for BTAI and are no longer available for purchase.
Learn more about the Zenith Alpha Thoracic Endovascular Graft recall
Abbott (formerly St. Jude Medical) Implantable Cardiac Pacemakers
The FDA approved a firmware update that is now available and is intended as a recall, specifically a corrective action, to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities for certain Abbott (formerly St. Jude Medical) pacemakers. The firmware update will be available beginning August 29, 2017. Pacemakers manufactured beginning August 28, 2017 will have this update pre-loaded in the device and will not need the update.
Learn more about the Abbott (formerly St. Jude Medical) implantable cardiac pacemaker alert
Forced Air Thermal Regulating Systems
The FDA is reminding healthcare providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients. The FDA recently became aware that some healthcare providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery). After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.
Learn more about the forced air thermoregulating systems alert
Foshan Flying Medical Products Alcohol Pads and Benzalkonium Chloride Antiseptic Towelettes
The FDA is alerting healthcare professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. These products are distributed by Total Resources International, Walnut, California, and Simple Diagnostics Inc., Williston Park, New York.
Learn more about the Foshan Flying Medical Products alcohol pads and benzalkonium chloride antiseptic towelettes alert
The FDA is recommending that patients avoid taking the potassium-lowering drug Kayexalate (sodium polystyrene sulfonate) at the same time as other medicines taken by mouth. A study found that sodium polystyrene sulfonate binds to many commonly prescribed oral medicines, decreasing the absorption and therefore effectiveness of those oral medicines. To reduce this likelihood, separating the dosing of sodium polystyrene sulfonate from other orally administered medicines by at least 3 hours is recommended. The sodium polystyrene sulfonate drug labels will be updated to include information about this dosing separation.
Learn more about Kayexalate
Keytruda in Patients with Multiple Myeloma
Based on data from two recently halted clinical trials, KEYNOTE-183 and KEYNOTE-185, the FDA issued a statement to inform about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda is not approved for treatment of multiple myeloma. On July 3, 2017, the FDA required that all patients in these trials be discontinued from further investigation with this drug because interim results from both trials demonstrated an increased risk of death for patients receiving Keytruda when it was combined with an immunomodulatory agent as compared to the control group.
Learn more about Keytruda in patients with multiple myeloma
Liquid-filled Intragastric Balloon Systems
The FDA is issuing an update to alert healthcare providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity. Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc.
Learn more about the liquid-filled intragastric balloon systems alert
Malaysian Herbal Coffee Products
The FDA is warning consumers not to drink Longjack Coffee or other instant coffee products that have been recalled recently, including Kopi Jantan Tradisional Natural Herbs Coffee, CaverFlo Coffee, and AMPT Coffee. These products are made in Malaysia and are promoted and sold online for sexual enhancement. CaverFlo Coffee and AMPT Coffee contain undeclared sildenafil and tadalafil; Longjack Coffee and Kopi Jantan Tradisional Natural Herbs Coffee contain undeclared desmethyl carbodenafil, an analogue of sildenafil.
Learn more about the Malaysian herbal coffee products alert