FDA New Approvals
Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System
The FDA approved a fully absorbable stent to treat coronary artery disease. The Absorb GT1 BVS, which releases the drug everolimus to limit the growth of scar tissue, is gradually absorbed by the body in approximately three years.
Learn more about the Absorb GT1 BVS System
AspireAssist Obesity Device
The FDA approved a new obesity treatment device that uses a surgically placed tube to drain a portion of the stomach contents after every meal. The AspireAssist device should not be used on patients with eating disorders, and it is not intended to be used for short durations in those who are moderately overweight. It is intended to assist in weight loss in patients aged 22 and older who are obese, with a body mass index of 35 to 55, and who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy.
Learn more about the AspireAssist Obesity Device
Raindrop Near Vision Inlay
The FDA approved the Raindrop Near Vision Inlay, a device implanted in the cornea of one eye to improve near vision in certain patients with presbyopia. It is used for correction of near vision in patients who have not had cataract surgery. The Raindrop Near Vision Inlay changes the shape of the cornea to achieve improved vision.
Learn more about the Raindrop Near Vision Inlay
Repatha Pushtronex System
Amgen announced that the FDA has approved the Repatha (evolocumab) Pushtronex system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option. The Pushtronex system is a hands-free device designed to provide 420mg of Repatha in a single dose. Repatha is a human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body's natural system for eliminating "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood. Repatha is the first and only PCSK9 inhibitor to offer a monthly single-dose delivery option.
Learn more about the Repatha Pushtronex System
U-500 Insulin Syringe
The FDA approved a dedicated syringe for the administration of Humulin R U-500 insulin, which is now the only device approved for use with U-500 insulin vial. Humulin R U-500 insulin vial has been available with no dedicated device for delivery since 1994. To administer the insulin, healthcare practitioners and patients had to make dose conversions to deliver the appropriate dose using a U-100 insulin syringe or a tuberculin (volumetric) syringe. Since conversions are no longer needed with this new device, the Humulin R U-500 insulin vial label will be updated to remove the dose conversion information for U-100 and tuberculin syringes. Approved syringes for use with Humulin R U-500 insulin vials will only be available with a prescription and should be co-prescribed with U-500 insulin. Humulin R U-500 is also available in a prefilled pen device as well as a vial. For patients that do not use the pen, the vial can be used as an alternative.
Learn more about U-500 Insulin Syringe
announced that it has received marketing approval from the FDA for Vaxchora (cholera vaccine,
live, oral), a single-dose oral,
live attenuated cholera vaccine indicated for use in adults 18 to 64 years of
age. Vaxchora is indicated for active immunization against disease caused by Vibrio cholerae serogroup O1.
Learn more about Vaxchora
The FDA approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 antagonist, approved by the FDA for dry eye disease.
Learn more about Xiidra
Xpert Carba-R Assay
FDA cleared for marketing the Xpert Carba-R Assay, an infection control aid
that tests patient specimens to detect specific genetic markers associated with
bacteria that are resistant to carbapenem antibiotics. Carbapenem antibiotics
are widely used in hospitals to treat severe infections. These resistant
organisms are commonly referred to as carbapenem-resistant Enterobacteriaceae,
or CRE, and have been reported in almost all states within the U.S.
Learn more about the Xpert Carba-R Assay
FDA New Indications
Novartis announced that the FDA has approved an expanded age range for
Xolair (omalizumab) to include children six to 11 years of age with moderate to
severe persistent asthma, having a positive skin test or in vitro reactivity
to an airborne allergen (perennial aeroallergen) and symptoms that are
inadequately controlled with inhaled corticosteroids. The previous age range
for the asthma indication of Xolair was 12 years and older. This approval comes
three months ahead of the FDA action date.
Learn more about Xolair
Dream Body Weight Loss
Dream Body Weight Loss is voluntarily recalling all lots of Dream Body Extreme Gold 800mg 30 gold capsules, Dream Body 450mg 30 white capsules, and Dream Body Advanced 400mg 30 purple capsules to the consumer level. The Dream Body Extreme Gold 800mg, Dream Body 450mg, and Dream Body Advanced 400mg have been found to contain sibutramine after FDA sampling and testing. The product is used as a dietary supplement and is packaged in clear packer jars and brown foil packets. The affected Dream Body 450mg, Dream Body Extreme Gold 800mg, and Dream Body Advanced 400mg with UPC codes 6903023120128 were distributed nationwide from January 2013 to June 16, 2016 to consumers via retail sales and internet transactions.
Learn more about Dream Body Weight Loss
HeartWare Ventricular Assist Device (HVAD) Batteries
HeartWare Inc. is recalling the batteries because they may lose power prematurely due to faulty cells. If the HVAD system is not connected to an additional power source shortly after the system sounds an alarm indicating a low battery level, the pump will stop working and the patient may experience serious adverse health consequences, including death. This recall includes batteries used on HVAD, Serial numbers: BAT000001 to BAT199999, Model number 1650, manufacturing dates: May 19, 2013 to July 1, 2015 and distribution dates: May 21, 2013 to July 31, 2015. A total of 18,631 units were recalled nationwide, including Washington D.C.
Learn more about HVAD Batteries
Canagliflozin and Dapagliflozin
The FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, the warnings in the drug labels have been revised to include information about acute kidney injury and added recommendations to minimize this risk.
Learn more about Canagliflozin and Dapagliflozin
International Operation Pangea IX
The FDA, in partnership with international regulatory and law enforcement agencies, announced that it took action this week against 4,402 websites that illegally sell potentially dangerous, unapproved prescription drugs to U.S. consumers. This effort was part of Operation Pangea IX, the Ninth Annual International Internet Week of Action, a global cooperative effort, led by INTERPOL, to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products on the internet.
Learn more about International Operation Pangea IX
Zecuity manufacturer Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity patch (sumatriptan). Healthcare professionals should discontinue prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine.
Learn more about Zecuity