FDA New Approvals
AirDuo RespiClick & ArmonAir RespiClick
Teva announced that the FDA has approved two products for adolescent and adult patients with asthma. These products, AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) and ArmonAir RespiClick (fluticasone propionate inhalation powder), include medication delivered via Teva’s RespiClick breath-activated, multi-dose dry powder inhaler which is used with other approved medicines in Teva’s respiratory product portfolio. AirDuo is a fixed dose combination product containing the same active ingredients as Advair for the treatment of asthma in patients aged 12 years and older. ArmonAir RespiClick is an inhaled corticosteroid containing the same active ingredient as Flovent, and is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years and older.
Learn more about AirDuo RespiClick and ArmonAir RespiClick
The FDA approved Emflaza (deflazacort) tablets and oral suspension to treat patients aged 5 years and older with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness. Emflaza is a corticosteroid that works by decreasing inflammation and reducing the activity of the immune system. Corticosteroids are commonly used to treat DMD across the world. This is the first FDA approval of any corticosteroid to treat DMD and the first approval of deflazacort for any use in the United States. Emflaza is marketed by Marathon Pharmaceuticals.
Learn more about Emflaza
Amgen announced that the FDA has approved Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis. Parsabiv is the first therapy approved for this condition in 12 years and the only calcimimetic that can be administered intravenously by the dialysis healthcare team three times a week at the end of the hemodialysis session.
Learn more about Parsabiv
Allergan announced that the FDA has
approved Rhofade (oxymetazoline
hydrochloride) cream, 1% for the topical
treatment of persistent facial redness in adults with rosacea. Rhofade is an alpha1A adrenoceptor agonist approved by
the FDA to treat facial redness in rosacea and is indicated to be used topically once daily. Rhofade will be available for commercial supply
starting May 2017.
Learn more about Rhofade
Tridesilon Cream, 0.05%
Encore Dermatology Inc. has announced the availability of Tridesilon (desonide) Cream, 0.05% in a 60g tube. Tridesilon Cream, 0.05% is a low-potency corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The medication should not be used longer than two weeks and is contraindicated in patients with a history of hypersensitivity to any of the components of the preparation. It is available in the U.S. by prescription only.
Learn more about Tridesilon Cream, 0.05%
Synergy Pharmaceuticals announced that the FDA approved Trulance (plecanatide) for the treatment of chronic idiopathic constipation (CIC) in adult patients. CIC is defined as persistent constipation for which there is no concrete structural or biochemical explanation. Trulance is taken orally once a day and works by stimulating intestinal fluids in the upper GI tract to provide regular bowel function. The safety and effectiveness profile has not been established in patients less than 18 years of age.
Learn more about Trulance
Teva announced that the FDA has approved Vantrela ER (hydrocodone bitartrate) extended-release tablet (CII), an opioid agonist used to manage severe pain that requires daily, around-the-clock, long-term opioid treatment in which alternate treatment options are inadequate. The product’s abuse-deterrent properties are expected to decrease opioid abuse by reducing manipulation of the drug. Vantrela ER is associated with serious risks and contains a boxed warning stating the adverse effects associated with use.
Learn more about Vantrela ER
FDA First-Time Generic Approvals
The FDA has announced the approval of the first generic version of Xyrem (sodium oxybate) oral solution, a medication indicated for treatment of cataplexy and excessive daytime sleepiness associated with narcolepsy. Sodium oxybate is the only medication approved to treat cataplexy in patients with narcolepsy, and the generic version will be controlled under the Risk Evaluation and Mitigation Strategy (REMS) program, with strict safety controls comparable to those currently required for Xyrem. Sodium oxybate will not be available at retail pharmacies and will be dispensed only to enrolled patients by certain pharmacies that ship directly to patients.
Learn more about sodium oxybate
FDA Labeling Changes
The FDA has approved a supplemental new drug application to update the
label for ceftazidime-avibactam (Avycaz,
Allergan) to include data from two phase 3 trials, "supporting the
indication to treat patients with complicated urinary tract infections (cUTI), including
pyelonephritis, caused by designated susceptible Gram-negative
microorganisms," the company has announced. Avycaz is indicated for the treatment of patients aged 18 years and older
with cUTI, including pyelonephritis caused by the following susceptible
Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae,
Citrobacter freundii complex, Proteus mirabilis,
and Pseudomonas aeruginosa. Avycaz is also
FDA-approved in combination with metronidazole (multiple brands) for treatment of complicated intra-abdominal
infections caused by the following susceptible Gram-negative microorganisms: E. coli, K. pneumoniae, P. mirabilis, E. cloacae, Klebsiella oxytoca,
C. freundii complex, and P. aeruginosa in patients aged 18 years and older.
Learn more about Avycaz
The prescribing information for the oral multiple sclerosis medication dimethyl fumarate (Tecfidera, Biogen) has been updated to include a warning of potential liver injury that could require hospitalization. The new information notes that clinically significant cases of liver injury have been reported in patients treated with the drug in the post-marketing setting. The onset has ranged from a few days to several months after initiation of treatment. Biogen said that 14 cases of liver injury have occurred among approximately 230,000 patients treated with the drug. The company added that the label changes were finalized with the FDA on January 19, 2017.
Learn more about Tecfidera
FDA New Formulations
Kaléo announced that Auvi-Q
(epinephrine injection, USP) Auto-injector will
be available by prescription in the U.S. again starting February 14, 2017.
Auvi-Q is an epinephrine auto-injector used to treat life-threatening allergic
reactions, including anaphylaxis, in patients with a history of serious allergic reactions and comes with
innovative features, such as a retractable needle and voice instructions. Kaléo also announced that an
access program, called Auvi-Q AffordAbility, will allow eligible patients with high-deductible
plans or no commercial or government insurance to have affordable access to the
Learn more about Auvi-Q
Allergan plc and Ironwood Pharmaceuticals have announced that the FDA approved the 72mcg dosage strength for Linzess (linaclotide), a guanylate cyclase-C agonist indicated for the treatment of chronic idiopathic constipation (CIC). CIC is a gastrointestinal disorder that results in infrequent bowel movements (less than three times per week) and can also result in hard stools. This is the third and lowest dosage strength that is approved for Linzess. It is estimated to have a lower rate of adverse events related to diarrhea, a common side effect of the medication, and will be available in the first quarter of 2017.
Learn more about Linzess
Adapt Pharma announced that the FDA approved a 2mg formulation of Narcan (naloxone hydrochloride) nasal spray, an opioid antagonist used for emergency treatment in patients with known or suspected opioid overdose. Narcan was originally approved in November 2015 in a 4mg ready-to-use, needle-free formulation. The 2mg dose is approved for use in opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.
Learn more about Narcan
FDA New Indications
AbbVie has announced that the FDA granted an accelerated approval of Imbruvica (ibrutinib) for the treatment of patients with relapsed/refractory marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20-based therapy. This indication is approved under accelerated approval based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. This is the fifth FDA-approved indication for Imbruvica since the medicine was launched in 2013.
Learn more about Imbruvica
The FDA granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb Company) for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy. The recommended dose and schedule for nivolumab for the above indication is 240mg intravenously every 2 weeks.
Learn more about Opdivo
AstraZeneca announced that the FDA has
approved Symbicort (budesonide/formoterol fumarate dehydrate) 80/4.5mcg for the treatment of asthma in patients aged 6
up to 12 years. Symbicort is a combination inhaler that contains an inhaled
corticosteroid and a long-acting beta2-agonist bronchodilator. Symbicort
80/4.5mcg and 160/4.5mcg are FDA approved for the treatment of asthma in
patients 12 years and older and for
maintenance therapy of COPD in adults. Symbicort contains a boxed warning about
the increase in risk of asthma-related death and is
not indicated for the relief of acute bronchospasm.
Learn more about Symbicort
Halo One Thin-Walled Guiding Sheath
Bard Peripheral Vascular Inc. is recalling the Halo One Thin-Walled Guiding Sheath because the sheath body may separate from the sheath hub while removing the device from the patient's leg. The company also reports that the sheath may kink and that its tip may become damaged during the procedure. The use of affected sheaths may result in prolonged procedure times and additional surgical intervention to remove detached components from the patient. The affected product may cause other serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death. The Halo One Thin-Walled Guiding Sheath is used to introduce and/or guide the placement of interventional and diagnostic devices into veins and arteries through an incision made on a patient's leg.
Learn more about the Halo One Thin-Walled Guiding Sheath
Legacy 250/450 Duodenoscopes
Fujifilm Medical Systems has announced its plans to remove the 250/450 duodenoscope models from clinical use based on the limited number of the models currently in use. Fuji will replace the 250/450 duodenoscope models with the ED-530XT model and necessary accessories at no cost. In addition, the FDA recommends that users and healthcare facilities apply the revised reprocessing instructions for the ED-530XT duodenoscope to reprocess the older 250/450 duodenoscope models while they are still in use. In December 2015, Fuji issued validated manual reprocessing instructions for the ED-530XT duodenoscope to replace those provided in the original device labeling.
Learn more about legacy 250/450 duodenoscopes
NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents
BioMerieux is recalling additional affected product lots and an additional product, the NucliSENS Magnetic Extraction Reagents, as a continuation of the previous recall for NucliSENS easyMAG Magnetic Silica. The recall is due to a quality problem in the magnetic silica component. The NucliSENS easyMAG Magnetic Silica is used to extract nucleic acids, RNA or DNA, that can be used for molecular infectious disease, molecular oncology, and molecular genetics assays. Kits with the affected lots of the magnetic silica may not be able to fully extract nucleic acids from the sample and detect infection or provide proper diagnosis. The detection problem could lead to a risk of false negative results, invalid results, or under-quantification for clinical laboratory tests. This error may result in inappropriate treatment or delay in treatment. The use of the affected product may cause serious adverse health consequences, including death.
Learn more about NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents
Vancomycin Hydrochloride for Injection
The FDA has announced that Hospira, Inc. is voluntarily recalling one lot of Vancomycin HCl for Injection, USP LOT 591053A EXP: 11. 01. 2017 NDC 0409-6510-01 (distributed August 2016 through September 2016) due to a confirmed customer report for the presence of particulate matter within a single vial. Vancomycin HCl is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci. If particulate is administered to a patient, it may result in swelling, irritation of blood vessels or tissues, blockage of blood vessels, and/or allergic response to the particulate. Hospira will be notifying its customers through a recall letter and is arranging for the product to be returned to Stericycle in the United States. Anyone who has inventory from the recalled lot should stop use and distribution and quarantine the product immediately.
Learn more about Vancomycin HCl for Injection
The FDA is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. As a result, we are requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts labels. Prescription chlorhexidine gluconate mouthwashes and oral chips used for gum disease already contain a warning about the possibility of serious allergic reactions in their labels. Chlorhexidine gluconate is mainly available in OTC products to clean and prepare the skin before surgery and before injections in order to help reduce bacteria that potentially can cause skin infections. These products are available as solutions, washes, sponges, and swabs and under many different brand names and as generics. Chlorhexidine gluconate is also available as a prescription mouthwash to treat gingivitis and as a prescription oral chip to treat periodontal disease.
Learn more about chlorhexidine gluconate
ED-3490TK Video Duodenoscope by Pentax
The FDA is providing an important update to the February 19, 2016 safety communication to inform users about a design issue with the Pentax ED-3490TK duodenoscope that could increase the risk of patient infection. This safety communication contains updated recommendations to help prevent spread of infection associated with the use of these devices. In February 2016, Pentax issued reprocessing procedures for the duodenoscopes due to the potential risk associated with the design of the device. The cracks and gaps in the adhesive that seals the device’s distal cap to its distal tip can lead to microbial and fluid ingress, increasing the risk of infection transmission among patients. The FDA recommends that facilities and staff implement the updated reprocessing procedures for Pentax’s ED-3490TK Video Duodenoscope.
Learn more about the ED-3490TK Video Duodenoscope by Pentax
Homeopathic Teething Products
The FDA announced that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products. Homeopathic teething products have not been evaluated or approved by the FDA for safety or effectiveness and the agency recommends seeking advice from healthcare professionals for safe alternatives. If a child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after use of homeopathic teething products, consumers should seek immediate medical care.
Learn more about homeopathic teething products
Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment
The FDA has received reports of serious adverse events, including patient injury and death, associated with the use of implantable infusion pumps in the MR environment. These reports describe medication dosing inaccuracies (e.g., over-infusion or under-infusion, unintended bolus) and other mechanical problems with the pump (e.g., motor stall, pump not restarting after a magnetic resonance imaging (MRI) exam). Only implantable infusion pumps labeled as MR Conditional may be used safely within an MR environment, and only under the specified conditions of safe use. The specific conditions that healthcare practitioners and patients should follow before, during, and after the MRI exam vary by the make and model of the implantable infusion pump system. Importantly, each implantable pump model may have unique conditions that must be followed in order for a patient to safely undergo an MRI exam. Failure to adhere to these conditions can result in serious injury or death.
Learn more about implantable infusion pumps in the MR environment
LIFEPAK 1000 Defibrillators by Physio-Control
Physio-Control has announced that it will be launching a voluntary field action for the LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment. The company has received 34 reports where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to an intermittent connection between the battery and device electrical contacts. A defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious harm or death. The company is aware of 8 adverse events related to this issue. The company is advising customers to immediately remove and reinstall the battery from this device and to implement a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices. Physio-Control will be initiating a hardware device correction for all affected devices and will contact customers to schedule device corrections once it is ready for implementation.
Learn more about LIFEPAK 1000 defibrillators by Physio-Control
The FDA is warning consumers not to purchase or use PNC-27, a product
promoted and sold through http://PNC27.com, as a treatment or cure for cancer.
An FDA laboratory discovered the bacteria Variovorax paradoxus
in a PNC-27 solution sample for inhalation. Consumers who use a contaminated
product are at risk for serious,
potentially life-threatening infections. Consumers
at higher risk include vulnerable populations, such as young children, elderly people, pregnant women, and individuals
with weakened immune systems. PNC-27 may be available in various dosage forms,
such as a nebulized solution, intravenous solution, vaginal suppository, or
rectal suppository. The FDA has not evaluated or approved PNC-27 as safe and effective to treat any disease, including any
form of cancer. The FDA recommends patients with cancer discuss treatment
options with a licensed healthcare professional. Patients who have used any
PNC-27 product and have concerns should contact their healthcare provider as soon as possible.
Learn more about PNC-27