Product Approval Summaries

DEVICES

FDA has cleared an AtriCure 510(k) for its AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion System that is designed for “increased functionality” than its previous model when occluding the LAA during surgical procedures. The device features an “ambidextrous locking and trigger-style clip closing mechanism, handle-based active articulation levers, and a hoopless end effector,” the company says. The ambidextrous locking and trigger-style clip closing mechanism is intended to allow operators to “maintain focus on the LAA while maneuvering the device,” it says. “The handle-based active articulation levers allow the operator to steer the end effector without removing the device. The hoopless end effector enhances anatomical visualization, and simplifies removal of the applier after deployment of the clip.”

FDA has approved Boston Scientific’s ImageReady MR-Conditional Pacing System, which includes Accolade MRI and Essentio MRI pacemakers, and the Ingevity MRI pacing leads, designed to treat bradycardia. The company says patients implanted with the full system are able to receive full-body MR scans in 1.5 Tesla environments when conditions of use are met. It adds that the Ingevity MRI pacing leads include active and passive fixation models, which is the first time a passive fixation pacing lead is approved for U.S. patients undergoing MR scans.

FDA has cleared an Exactech 510(k) to market its Vantage Total Ankle to treat patients who suffer from arthritis in the ankle. The device is designed with a curved surface talar component that is engineered to fit the anatomy of the diseased talus and restore the joint line. It also offers anatomic tibia designs that are intended to “improve implant stability and return anatomic kinematics,” the company says. The system also incorporates a “press-fit bone cage design” used in the company’s Equinoxe shoulder system that allows for initial and long-term fixation, it says.

Intuity Medical, Inc. has received FDA clearance to market the POGO Automatic Blood Glucose Monitoring System. According to the company, it is the first blood glucose meter and multi-test cartridge to provide automatic testing with lancing, blood collection and analysis in one step.

Royal Philips has received FDA 510(k) clearance for its suite of low-dose CT solutions to screen lung cancer. The suite includes 27 CT and PET/CT models and integrated software and services.

HUMAN DRUGS

FDA has approved an AbbVie supplemental NDA for the use of Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin in patients with genotype 1b chronic hepatitis C virus infection and compensated cirrhosis (Child-Pugh A).

Allergan plc has received final approval from FDA on its ANDA for rosuvastatin calcium 5, 10, 20 and 40 mg tablets, the generic version of AstraZeneca’s Crestor (rosuvastatin) tablets, for use in combination with diet for treating high triglycerides in adults, for use in combination with diet for treating patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia), a disorder associated with improper breakdown of cholesterol and triglycerides, and for use either alone or in combination with other cholesterol treatment for adult patients with homozygous familial hypercholesterolemia, a disorder associated with high low-density lipoprotein cholesterol.

AstraZeneca has received FDA approval of an NDA for Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol, indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. The product is not indicated for treating asthma or for relieving acute bronchospasm.

Bayer has received FDA approval of Gadavist (gadobutrol) injection for use with magnetic resonance angiography to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients (including term neonates).

FDA has approved a Collegium Pharmaceutical NDA for Xtampza ER (oxycodone) extended-release capsules, a twice-daily medication for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Xtampza uses the company’s proprietary DETERx technology platform, which it says is designed to provide adequate pain control while maintaining its drug release profile after being subjected to common methods of manipulation, including product chewing and crushing prior to administration.

FDA has approved Eisai Inc.’s Fycompa (perampanel) CIII oral suspension as adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older. The company says the oral suspension formulation is a bioequivalent to the Fycompa tablet formulation, and is expected to be available to patients in June.

FDA has approved an Exelixis NDA for Cabometyx (cabozantinib) tablets for treating patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. RCC is the most common form of kidney cancer in adults.

Perrigo Company has received final FDA approval for the generic version of Valeant Pharmaceutical International’s BenzaClin Pump Topical Gel (clindamycin phosphate 1% and benzoyl peroxide 5%), indicated for the topical treatment of acne vulgaris.

FDA has granted approval to Swedish Orphan Biovitrum AB (Sobi), for Orfadin Oral Suspension 4 mg/mL for treating Hereditary Tyrosinemia Type 1 (HT-1) for use in combination with dietary restriction of tyrosine and phenylalanine. The company says the new formulation is an alternative to the capsules and provides an additional option for infants and small children.

FDA has cleared a Potrero Medical 510(k) for the Accuryn Monitoring System, a diagnostic urinary catheter for patients requiring tight fluid management, including patients at risk of sepsis and acute kidney injury. The device is designed to provide accurate, real-time urine output, intra-abdominal pressure, and temperature measurement, according to the company. By automatically clearing the drain line, Accuryn enables accurate urine output and reduced urinary retention — a known risk for catheter associated urinary tract infection, it says. “Accuryn is also designed to improve clinical workflow by eliminating manual intervention of drain line blockages and by providing out-of-the box [electronic medical record] integration,” Potrero says.

Teva Pharmaceutical Industries has received FDA approval of a supplemental NDA for ProAir RespiClick (albuterol sulfate) Inhalation Powder for treating or preventing bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for preventing exercise-induced bronchospasm. The product was originally approved in 2015 for patients 12 years of age and older.