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  • FDA Drug Updates

    FDA New Approvals


    Alkermes announced that the FDA has approved Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. Aristada is an atypical antipsychotic with once-monthly and six-week dosing options for delivering and maintaining therapeutic levels of medication in the body through an injection. Alkermes is preparing to launch Aristada immediately. Learn more about Aristada


    The FDA is warning healthcare professionals about the risk for dosing errors with the intravenous antibacterial drug Avycaz (ceftazidime and avibactam) due to confusion about the drug strength displayed on the vial and carton labels. Avycaz was initially approved with the vial and carton labels displaying the individual strengths of the two active ingredients (i.e., 2 gram/0.5 gram); however, the product is dosed based on the sum of the active ingredients (i.e., 2.5 gram). To prevent medication errors, the FDA revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram. Learn more about Avycaz

    Cobas Influenza A/B Test

    Roche announced that the FDA has granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for the Cobas influenza A/B test for use on the Cobas Liat system. Coupled with the CLIA-waived Cobas strep A test, the Cobas influenza A/B test can now be used by healthcare providers in non-traditional testing sites, including physician offices, emergency rooms, health department clinics, pharmacy clinics, and other healthcare facilities. Learn more about the Cobas Influenza A/B Test

    Juvederm Ultra XC

    Allergan announced that the company has received approval from the FDA to market Juvederm Ultra XC for injection into the lips and perioral area for lip augmentation in adults over the age of 21. Juvederm Ultra XC instantly adds fullness to the lips and is the only dermal filler that has proven results lasting up to one year for lip augmentation. Learn more about Juvederm Ultra XC


    Taiho Oncology, Inc. announced that the FDA approved Lonsurf (trifluridine and tipiracil), formerly known as TAS-102, for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. Learn more about Lonsurf


    Octapharma USA announced the FDA has approved Nuwiq (antihemophilic factor [recombinant]), an intravenous therapy for adults and children living with hemophilia A. The Nuwiq approval includes on-demand treatment and control of bleeding episodes; routine prophylaxis to reduce the frequency of bleeding episodes; and perioperative management of bleeding. Octapharma USA aims to have Nuwiq available in the US marketplace by early 2016. Learn more about Nuwiq

    Opdivo + Yervoy in BRAF V600 Wild-Type Unresectable or Metastatic Melanoma

    Bristol-Myers Squibb Company announced that the FDA approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. This indication is approved under accelerated approval based on tumor response rate and durability of response. Learn more about the Opdivo + Yervoy regimen

    Tresiba and Ryzodeg 70/30

    The FDA has approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus. Tresiba is a long-acting insulin analog. Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. Tresiba and Ryzodeg are manufactured by Novo Nordisk. Learn more about Tresiba and Ryzodeg 70/30


    Allergan and Gedeon Richter announced that the FDA has approved Vraylar (cariprazine) capsules, an atypical antipsychotic, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treatment of schizophrenia in adults. Learn more about Vraylar

    FDA New Indications


    AbbVie announced that the FDA approved Humira (adalimumab) for the treatment of moderate to severe hidradenitis suppurativa (HS). Humira is now the first FDA-approved therapy for adults with HS. Learn more about Humira


    Merck announced that the FDA has approved Keytruda (pembrolizumab) monotherapy, the company’s anti-programmed death (PD) receptor-1 therapy, at a dose of 2mg/kg every three weeks, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda. Under the FDA’s accelerated approval regulations, this indication for Keytruda is approved based on tumor response rate and durability of response. Learn more about Keytruda


    Novocure announced that the FDA has approved Optune in combination with temozolomide for the treatment of adult patients with newly diagnosed glioblastoma. Optune is a portable, non-invasive device that delivers low-intensity, intermediate frequency, alternating electric fields—referred to as tumor treating fields—that inhibit cancer cell replication and cause cancer cell death. Learn more about Optune

    Spiriva Respimat

    Boehringer Ingelheim announced that the FDA approved Spiriva Respimat (tiotropium bromide) inhalation spray for use in the treatment of asthma. It is approved by the FDA for the long-term, once-daily, maintenance treatment of asthma in patients 12 years of age and older. Learn more about Spiriva Respimat

    FDA Recalls

    Baidyanath Ayurvedic Dietary Supplements

    Consumers who have used any of the Baidyanath brand Ayurvedic dietary supplements listed in the Consumer Advice Notice should stop using them and consult their healthcare provider. Testing by the New York Department of Health and the FDA has found that these products contain high levels of lead and/or mercury, which can cause serious health problems. Learn more about Baidyanath Ayurvedic dietary supplements

    Freedom Driver Systems

    The FDA notified healthcare professionals of a Class I Recall of the Freedom Driver Systems used with the SynCardia temporary Total Artificial Heart. A specific part of the Freedom Driver drive mechanism may fail and cause the device to stop pumping. Patients do not receive any advanced warning that the device may fail. If it does fail, a red light located in the center of the driver, towards the top, will stay red and a loud continuous alarm will sound. However, if the Freedom Driver stops pumping, the patient will lose consciousness almost immediately, which means that the warning light and alarm may not be helpful. The patient will likely experience serious injury or death if not immediately switched to a backup driver by a caregiver. Learn more about Freedom Driver Systems

    Pink Bikini and Shorts on the Beach

    Lucy's Weight Loss System is voluntarily recalling all lots distributed May 25–June 23, 2015 of Pink Bikini and Shorts on the Beach Blue and Gold Edition, 30 blue capsules (750mg per capsule) and 30 gold capsules (800mg per capsule) to the consumer level. Pink Bikini and Shorts on the Beach have been found positive for sibutramine and phenolphthalein after FDA sampling and testing. Learn more about Pink Bikini and Shorts on the Beach

    Profemur Neck Varus/Valgus CoCR, Part Number PHAC1254

    MicroPort Orthopedics Inc. has received reports of an unexpected rate of fractures after surgery related to this specific modular neck. If the modular neck fractures, the patient may experience sudden pain, instability, and difficulty walking and performing common tasks. An acute fracture will require revision surgery to remove and replace the neck and stem components. Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, and even death. Learn more about Profemur Neck Varus/Valgus CoCR, Part Number PHAC1254

    TF Supplements

    TF Supplements is voluntarily recalling the following product to the consumer level: RHINO 7 packaged in a bottle containing six (6) capsules with lot# K824B719-P and in a single (1) count capsule hang card with lot# SU-5102617*RP at the consumer level. Lot numbers are on the back top right of the (1) count and on the side of the (6) count bottle. FDA analysis found these products to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase PDE-5 inhibitor, which is a class of drugs used to treat male erectile dysfunction, making these products unapproved new drugs. Dapoxetine is an active ingredient not approved by the FDA. Learn more about TF Supplements

    US Compounding, Inc. Sterile Compounded Products

    US Compounding, Inc. (USC) is voluntarily recalling all lots of sterile products aseptically compounded and packaged by USC and that remain within expiry due to the FDA’s concern over a lack of sterility assurance. The sterile products were distributed nationwide to patients, providers, hospitals, or clinics between March 14, 2015 and September 9, 2015. The recall does not pertain to any non-sterile compounded medications prepared by USC. Learn more about USC Sterile Compounded Products

    FDA Alerts

    Bioprosthetic Aortic Valves

    The FDA is aware of recent reports regarding reduced leaflet motion in some bioprosthetic aortic valves, including both SAVR and TAVR devices. Importantly, most cases of reduced leaflet motion were discovered by advanced imaging studies in patients without symptoms of abnormal bioprosthetic valve function. Further, these studies have shown that in valves with reduced motion of one or more individual leaflets, there was acceptable forward blood flow through the valve opening without evidence of stenosis. Learn more about Bioprosthetic Aortic Valves


    The FDA has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures, and added new information about decreased bone mineral density. To address these safety concerns, the FDA added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels. Learn more about Canagliflozin


    The FDA is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about a serious blood condition called severe neutropenia. There are two parts to the changes in the requirements for treating patients with clozapine. First, the FDA clarified and enhanced the prescribing information for clozapine that explains how to monitor patients for neutropenia and manage clozapine treatment. Second, the FDA approved a new, shared Risk Evaluation and Mitigation Strategy (REMS) called the Clozapine REMS Program. Learn more about Clozapine

    Cranial Perforators with an Automatic Clutch Mechanism

    Most cranial perforators are designed to automatically stop drilling after penetrating the skull to prevent the tip from unintentionally drilling or “plunging” into the brain. However, this clutch mechanism may fail to disengage if proper use, patient considerations, and device selection are not followed in accordance with the manufacturer’s instructions for use. The clinical consequences of cranial perforators failing to disengage can be serious. From January 2005 through August 2015, the FDA received over 300 medical device reports associated with the use of cranial perforators with an automatic clutch mechanism failing to disengage, resulting in over 200 injuries. Learn more about Cranial Perforators with an Automatic Clutch Mechanism

    HeartMate II Left Ventricular Assist System (LVAS)

    Thoratec Corporation issued a voluntary Urgent Medical Device Correction Letter to all hospitals who have patients supported with the HeartMate II LVAS reminding them to monitor the expiration date of the backup battery contained within the HeartMate II "Pocket" System Controller, as specified in the product Instructions for Use. This backup battery has a 36-month expiration date. If allowed to expire, an advisory alarm, indicated by a yellow wrench symbol, is triggered. This alarm occurs at 12:00 a.m. on the first day of the month in which the backup battery expires. It is important to note that exceeding the backup battery expiration and any associated advisory (or "yellow wrench") alarms do not affect normal HeartMate II LVAS function. While the HeartMate II LVAS Instructions for Use provides information on monitoring and changing the backup battery before it reaches the 36-month expiration date, Thoratec has recently received reports of patients experiencing advisory alarms for expired System Controller backup batteries. Learn more about the HeartMate II LVAS

    Park Compounding Pharmacy

    During the FDA’s recent inspection of Park Compounding Pharmacy’s facility, FDA investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about the company’s ability to assure the sterility of drug products that it produced. The FDA is alerting healthcare professionals and patients not to use drug products intended to be sterile made and distributed by Chen Shwezin Inc., doing business as Park Compounding Pharmacy. Learn more about Park Compounding Pharmacy

    Reprocessed Flexible Bronchoscopes

    The FDA has undertaken an ongoing, comprehensive investigation into infections associated with reprocessed reusable medical devices, working with federal partners, manufacturers, and other stakeholders to better understand the critical factors contributing to device-associated patient infection and how to best mitigate them. In the March 2015 Reprocessing Final Guidance, the FDA identified bronchoscopes as being part of a subset of devices that pose a greater likelihood of microbial transmission and represent a high risk of infection if they are not adequately reprocessed, so the FDA is proactively investigating these devices to determine if additional steps should be taken. Learn more about Reprocessed Flexible Bronchoscopes


    The FDA is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. The FDA is evaluating all available information and will communicate final conclusions and recommendations to the public when the review is complete. Tramadol is not FDA-approved for use in children; however, data show it is being used “off-label” in the pediatric population. Healthcare professionals should be aware of this and consider prescribing alternative FDA-approved pain medicines for children. Learn more about Tramadol